Baylor Biomedical Services
Country not established
- Devices
- 4
What Baylor Biomedical Services makes
Baylor Biomedical Services manufactures assistive communication devices, including voice output systems like the YES-NO VOICE BOX 7011 for individuals with limited speech, as well as remote control switches and rotary communication scanners for accessibility applications. Their product line also includes environmental control units, such as the Model 7000, designed to enable users to operate home or assistive devices through voice or switch activation.
The company’s devices are classified under FDA Class II and are listed via the 510(k) pathway, adhering to US regulatory requirements for medical devices. Their products are intended for use within the United States, where they are subject to compliance with the FDA’s regulatory framework for assistive and communication technologies.
Catalogue
Yes-No Voice Box 7011 Ref K901029
Regimes: 510(k) Registry: 510(k)Remote Control Switch Ref K900969
Regimes: 510(k) Registry: 510(k)Rotary Communication Scanner Model 7010 Ref K901030
Regimes: 510(k) Registry: 510(k)Environmental Control Unit Model 7000 Ref K901028
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Baylor Biomedical Services have in the registry?
The registry currently lists 4 devices for Baylor Biomedical Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baylor Biomedical Services's devices?
Among its 4 most recently registered devices, Baylor Biomedical Services has devices listed in FDA 510(k) (4 devices).
What risk classes do Baylor Biomedical Services's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Baylor Biomedical Services's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Baylor Biomedical Services in the registry?
The most recently registered devices listed for Baylor Biomedical Services include YES-NO VOICE BOX 7011, REMOTE CONTROL SWITCH, ROTARY COMMUNICATION SCANNER MODEL 7010 and ENVIRONMENTAL CONTROL UNIT MODEL 7000.