Telediagnostic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
What Telediagnostic Systems, Inc. makes
Telediagnostic Systems, Inc. manufactures medical devices for remote monitoring and diagnostic purposes, including EEG (electroencephalogram) monitoring systems like the M10 EEG Monitor Scope and DT-24 Telematic EEG Transmitter/Receiver pair. Their portfolio also includes polysomnography systems such as the Vista Polysomnography Computer System and Nightron Polysomnography System, designed for sleep studies. Additional products include biofeedback systems like the AlphaOne, telephonic receivers for EEG and polysomnography, and peripherals such as the OC-100 Oximeter Interface Calibrator and ISO-100 Isolation Amplifier.
The company’s devices are classified under FDA Class II and are subject to 510(k) premarket notification requirements in the United States. These products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution. The manufacturer is based in the US.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Telediagnostic Systems, Inc. have in the registry?
The registry currently lists 14 devices for Telediagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Telediagnostic Systems, Inc.'s devices?
Among its 14 most recently registered devices, Telediagnostic Systems, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Telediagnostic Systems, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Telediagnostic Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Telediagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Telediagnostic Systems, Inc. include M10 EEG MONITOR SCOPE, ISO-100 ISOLATION AMPLIFIER, ALPHAONE BIOFEEDBACK SYSTEM and RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER.