Madsen Electronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Madsen Electronics, Inc. makes
Madsen Electronics, Inc. manufactures audiological diagnostic equipment, including real-ear measurement systems like the RH2000 and hearing assessment devices such as the VOYAGER 522 and CAPELLA. Their portfolio also includes specialized tools like the CAPELLA Cochlear Emissions Analyzer, designed for objective hearing evaluations.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Voyager 522 Ref K945032
Regimes: 510(k) Registry: 510(k)RH2000 Real Ear Measurement System Ref K945199
Regimes: 510(k) Registry: 510(k)Capella Ref K002200
Regimes: 510(k) Registry: 510(k)Capella Cochlear Emissions Analyzer Ref K983851
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Madsen Electronics, Inc. have in the registry?
The registry currently lists 4 devices for Madsen Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Madsen Electronics, Inc.'s devices?
Among its 4 most recently registered devices, Madsen Electronics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Madsen Electronics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Madsen Electronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Madsen Electronics, Inc. in the registry?
The most recently registered devices listed for Madsen Electronics, Inc. include VOYAGER 522, RH2000 REAL EAR MEASUREMENT SYSTEM, CAPELLA and CAPELLA COCHLEAR EMISSIONS ANALYZER.