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Automated microscope system for immunofluorescent determination of autoantibodies.
IMMUNO CONCEPTS INC
IN110
In Commercial Distribution
- M74900IN1101 ()
IN110
- Cell morphology analyser IVD, automated/semi-automated
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482080 ()
CCZ1205048208
- Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482050 ()
CCZ1205048205
- Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482030 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Holter Server Analyzer
Lifesignals, Inc.
UA2251-SA
In Commercial Distribution
- B353UA2251SA1 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Holter Desktop Analyzer
Lifesignals, Inc.
UA2251-DA
In Commercial Distribution
- B353UA2251DA1 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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
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