Rastronics USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Rastronics USA, Inc. makes
Rastronics USA, Inc. manufactures diagnostic and analysis systems for hearing healthcare, including remote transmission units for tympanometry (e.g., HANDTYMP SCREENER Model 2000 with remote transducers), computer-based frequency response analyzers (e.g., CCI-10), and portable hearing aid analysis tools (e.g., PORTAREM 20). Their portfolio also covers standalone hearing aid analyzers (e.g., CCI 10/3 and CCI 8).
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
- Regimes: 510(k) Registry: 510(k)
Frequency Response Analyzer Computer Sys Cci-10 Ref K853320
Regimes: 510(k) Registry: 510(k)Rastronics Cci 10/3 Hearing Aid Analysis Ref K902252
Regimes: 510(k) Registry: 510(k)Rastronics Portarem 20 Ref K902287
Regimes: 510(k) Registry: 510(k)Rastronics Cci 8 Ref K902244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rastronics USA, Inc. have in the registry?
The registry currently lists 5 devices for Rastronics USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rastronics USA, Inc.'s devices?
Among its 5 most recently registered devices, Rastronics USA, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Rastronics USA, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Rastronics USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rastronics USA, Inc. in the registry?
The most recently registered devices listed for Rastronics USA, Inc. include HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS., FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10, RASTRONICS CCI 10/3 HEARING AID ANALYSIS and RASTRONICS PORTAREM 20.