Spec Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Spec Systems, Inc. makes
Spec Systems, Inc. manufactures hearing aids, including the SONIC Model 8711, and ultrasound cleaning devices such as the Model UCA / SPEC System UCA. These products are designed for auditory and ultrasonic applications in clinical and industrial settings.
The company’s portfolio includes Class I and Class II devices, with regulatory submissions recorded in the FDA 510(k) database. The manufacturer is based in the United States.
Catalogue
Sonic Model 8711 Hearing Aid Ref K821165
Regimes: 510(k) Registry: 510(k)Model Uca / Spec System Uca Ref K875305
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spec Systems, Inc. have in the registry?
The registry currently lists 2 devices for Spec Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spec Systems, Inc.'s devices?
Among its 2 most recently registered devices, Spec Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Spec Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spec Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spec Systems, Inc. in the registry?
The most recently registered devices listed for Spec Systems, Inc. include SONIC MODEL 8711 HEARING AID and MODEL UCA / SPEC SYSTEM UCA.