Gereonics, Inc.
United StatesFDA applicant, unverified FDA FEI 2025694
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Gereonics Ultra-Piezo Respiratory Effort Sensor Ref K983449
Regimes: 510(k) Registry: 510(k)Gereonics Biopotential Skin Electrodes Ref K861099
Regimes: 510(k) Registry: 510(k)Gereonics Ultra-Piezo Limb Movement Sensor Ref K062883
Regimes: 510(k) Registry: 510(k)Gereonics Ultra-Piezo Respiratory Effort Sensor Ref K991411
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 2025694
- Address
- 117 Sanctuary, Irvine, CA, 92620
Frequently asked questions
How many devices does Gereonics, Inc. have in the registry?
The registry currently lists 4 devices for Gereonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gereonics, Inc.'s devices?
Among its 4 most recently registered devices, Gereonics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Gereonics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gereonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gereonics, Inc. in the registry?
The most recently registered devices listed for Gereonics, Inc. include GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR, GEREONICS BIOPOTENTIAL SKIN ELECTRODES and GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR.