Nexera Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Nexera Medical, Inc. makes
Nexera Medical, Inc. manufactures surgical masks and N95 respirators designed for healthcare settings, including the SPECTRASHIELD 9500 Surgical Mask and SpectraShield 9500 Surgical N95 Respirator.
These products are classified as Class II devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Spectrashield 9500 Surgical Mask Ref K090414
Regimes: 510(k) Registry: 510(k)SpectraShield 9500 Surgical N95 Respirator Ref K150729
Regimes: 510(k) Registry: 510(k)Spectrashield 9500 Surgical N95 Respirator Ref K120244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nexera Medical, Inc. have in the registry?
The registry currently lists 3 devices for Nexera Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nexera Medical, Inc.'s devices?
Among its 3 most recently registered devices, Nexera Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Nexera Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nexera Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nexera Medical, Inc. in the registry?
The most recently registered devices listed for Nexera Medical, Inc. include SPECTRASHIELD 9500 SURGICAL MASK and SpectraShield 9500 Surgical N95 Respirator.