Madsen North America, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Madsen North America, Inc. makes
Madsen North America, Inc. manufactures audiometric equipment, including the MICROMATE 304, MIDIMATE 622, and VERA 103—devices used for hearing assessment and testing in clinical and diagnostic settings.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Micromate 304 Ref K896401
Regimes: 510(k) Registry: 510(k)Midimate 622 Ref K896710
Regimes: 510(k) Registry: 510(k)Vera 103 Ref K897143
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Madsen North America, Inc. have in the registry?
The registry currently lists 3 devices for Madsen North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Madsen North America, Inc.'s devices?
Among its 3 most recently registered devices, Madsen North America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Madsen North America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Madsen North America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Madsen North America, Inc. in the registry?
The most recently registered devices listed for Madsen North America, Inc. include MICROMATE 304, MIDIMATE 622 and VERA 103.