Novatec, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Novatec, Inc. makes
Novatec, Inc. manufactures the NOVATEC PRM, a device designed for prosthetic rehabilitation, and the DIGICUFF, a cuff-based system for monitoring physiological parameters during medical procedures.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Novatec Prm Ref K790450
Regimes: 510(k) Registry: 510(k)Digicuff Ref K820242
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novatec, Inc. have in the registry?
The registry currently lists 2 devices for Novatec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novatec, Inc.'s devices?
Among its 2 most recently registered devices, Novatec, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Novatec, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Novatec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novatec, Inc. in the registry?
The most recently registered devices listed for Novatec, Inc. include NOVATEC PRM and DIGICUFF.