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The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
Cerebra Medical Ltd
700014
In Commercial Distribution
- B600700014 ()
- Sleep disorder interpretive software, professional-only
The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
Cerebra Medical Ltd
1
In Commercial Distribution
- B6005537160 ()
- Sleep disorder interpretive software, professional-only
No Description
Dental Imaging Technologies Corporation
1.008.7934
In Commercial Distribution
- D090100879340 ()
- Radiology information system application software
No Description
PHILIPS FRANCE COMMERCIAL
2.4.x
In Commercial Distribution
- G637CEA0 ()
- Cardiopulmonary physiological parameter analysis software
No Description
DEXIS LLC
10
In Commercial Distribution
- EKAV100879340 ()
1.008.7934
- Radiology information system application software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202256RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202254RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202253OTC0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202252RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202251OTC0 ()
- Home pharmaceutical management support software