Fischer-Zoth Audiologic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Fischer-Zoth Audiologic Systems, Inc. makes
Fischer-Zoth Audiologic Systems, Inc. manufactures audiometric test booths, including the ECHO-SCREEN T, TA, TD, TDA, and TC models, designed for controlled acoustic environments in hearing assessments. These booths are engineered to minimize external noise interference and ensure accurate audiometric testing.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. device authorization requirements. The manufacturer operates from the United States.
Catalogue
Echo-Screen T, Ta, Td, Tda, Tc Ref K013977
Regimes: 510(k) Registry: 510(k)Echo-Screen Ref K982642
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fischer-Zoth Audiologic Systems, Inc. have in the registry?
The registry currently lists 2 devices for Fischer-Zoth Audiologic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fischer-Zoth Audiologic Systems, Inc.'s devices?
Among its 2 most recently registered devices, Fischer-Zoth Audiologic Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Fischer-Zoth Audiologic Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fischer-Zoth Audiologic Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fischer-Zoth Audiologic Systems, Inc. in the registry?
The most recently registered devices listed for Fischer-Zoth Audiologic Systems, Inc. include ECHO-SCREEN T, TA, TD, TDA, TC and ECHO-SCREEN.