Somnitec, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Somnitec, Inc. makes
Somnitec, Inc. manufactures reusable and disposable electrophysiological electrodes, including ECG snap electrodes designed for female-to-pin connections and gold cup EEG electrodes with integrated leads and extensions. The company also produces diagnostic devices such as the Somnimic and Somniprobe, which are used for monitoring and recording physiological signals, including those related to sleep studies.
These devices are classified under Class II by the FDA and are authorised through the 510(k) clearance process. Somnitec, Inc. is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Gold Cup Eeg Cutaneous Electrode W/Lead And Ext. Ref K911989
Regimes: 510(k) Registry: 510(k)Somnimic (R) Ref K912817
Regimes: 510(k) Registry: 510(k)Somniprobe(R) Model Number 10093, Modification Ref K912234
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Somnitec, Inc. have in the registry?
The registry currently lists 4 devices for Somnitec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Somnitec, Inc.'s devices?
Among its 4 most recently registered devices, Somnitec, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Somnitec, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Somnitec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Somnitec, Inc. in the registry?
The most recently registered devices listed for Somnitec, Inc. include ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT., GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT., SOMNIMIC (R) and SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION.