Calmed Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Calmed Technology, Inc. makes
Calmed Technology, Inc. manufactures audiometry devices, including screening audiometers for word recognition and identification testing, as well as the ProDigit 2000 personal digital audiometer for clinical assessments. Their portfolio includes game-based audiometry tools designed to evaluate hearing through word identification tasks.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Screening Audiometry Word Recognition Audiometry Ref K950888
Regimes: 510(k) Registry: 510(k)Prodigit 2000 Ref K940999
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Calmed Technology, Inc. have in the registry?
The registry currently lists 3 devices for Calmed Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calmed Technology, Inc.'s devices?
Among its 3 most recently registered devices, Calmed Technology, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Calmed Technology, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Calmed Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calmed Technology, Inc. in the registry?
The most recently registered devices listed for Calmed Technology, Inc. include SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY, PRODIGIT 2000 and GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM).