Precept, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Precept, Inc. makes
Precept, Inc. manufactures single-use patient care items, including disposable armboards and infant mittens with cuffs, as well as surgical face masks and disposable surgical face coverings.
The company’s products are regulated under FDA’s Class I and Class II categories, with relevant devices listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Mask, Surgical, Face, Disposable Ref K770463
Regimes: 510(k) Registry: 510(k)Cover, Armboard, Disposable Ref K770391
Regimes: 510(k) Registry: 510(k)Disp. Surgical Face Mask Ref K771409
Regimes: 510(k) Registry: 510(k)Mask, Face, Surgical Ref K770021
Regimes: 510(k) Registry: 510(k)Shirt, Mitten Cuff Infant Ref K760360
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Precept, Inc. have in the registry?
The registry currently lists 5 devices for Precept, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precept, Inc.'s devices?
Among its 5 most recently registered devices, Precept, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Precept, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Precept, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precept, Inc. in the registry?
The most recently registered devices listed for Precept, Inc. include MASK, SURGICAL, FACE, DISPOSABLE, COVER, ARMBOARD, DISPOSABLE, DISP. SURGICAL FACE MASK and MASK, FACE, SURGICAL.