Houston Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Houston Biomedical, Inc. makes
Houston Biomedical, Inc. manufactures diagnostic imaging devices, including the GASTROTOPO for gastrointestinal imaging, the UROTOPO catheter for urinary tract visualization, and the ANGIOTOPO catheter for vascular imaging.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Gastrotopo Ref K861291
Regimes: 510(k) Registry: 510(k)Urotopo Catheter Ref K861200
Regimes: 510(k) Registry: 510(k)Angiotopo Catheter Ref K861241
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Houston Biomedical, Inc. have in the registry?
The registry currently lists 3 devices for Houston Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Houston Biomedical, Inc.'s devices?
Among its 3 most recently registered devices, Houston Biomedical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Houston Biomedical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Houston Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Houston Biomedical, Inc. in the registry?
The most recently registered devices listed for Houston Biomedical, Inc. include GASTROTOPO, UROTOPO CATHETER and ANGIOTOPO CATHETER.