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No Description
Synaptive Medical Inc
1.1
In Commercial Distribution
- 00670082000115 ()
SYN-0578
- Radiological PACS software
No Description
Synaptive Medical Inc
1.3
Not in Commercial Distribution
- 00670082000085 ()
SYN-0004
- Radiological PACS software
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5736744
In Commercial Distribution
- 04049098053808 ()
- Patient monitoring system module, electroencephalographic
No Description
LIFE TECHNOLOGIES CORPORATION
A54762
In Commercial Distribution
- 10190302018135 ()
- Laboratory instrument/analyser application software IVD
The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and
recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing
an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring
equipment. This feature allows patients to comply with exercise prescriptions while exercising at a
medical/rehabilitation facility near their home, or by returning to the primary medical facility to
participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program
Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software File Manager
In Commercial Distribution
- 00856298006244 ()
101601
- Electrocardiography telemetric monitoring system
No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution
- 00851607003211 ()
- Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution
- 00851607003204 ()
- Manometric gastrointestinal motility analysis system
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution
- 00850013007295 ()
ELF002
- Audiometric/hearing device software
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
512 Channel
In Commercial Distribution
- 00850011306895 ()
36-0301-0045
- Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
480 Channel
In Commercial Distribution
- 00850011306888 ()
36-0301-0044
- Electroencephalographic monitoring system