Bloomfield Research and Development, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bloomfield Research and Development, Inc. makes
Bloomfield Research and Development, Inc. manufactures medical devices for auscultation and voice analysis, including the Decitel Auscultoscope—a stethoscope designed for clinical and diagnostic use—and the VOX Companion and P.O. VOX systems, which assess vocal function and speech production for diagnostic and therapeutic purposes.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer operates from the United States.
Catalogue
Decitel Ausculscope Ref K860994
Regimes: 510(k) Registry: 510(k)Vox Companion Ref K860992
Regimes: 510(k) Registry: 510(k)P.O. Vox Ref K860993
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bloomfield Research and Development, Inc. have in the registry?
The registry currently lists 3 devices for Bloomfield Research and Development, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bloomfield Research and Development, Inc.'s devices?
Among its 3 most recently registered devices, Bloomfield Research and Development, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bloomfield Research and Development, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bloomfield Research and Development, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bloomfield Research and Development, Inc. in the registry?
The most recently registered devices listed for Bloomfield Research and Development, Inc. include DECITEL AUSCULSCOPE, VOX COMPANION and P.O. VOX.