Sounmed, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sounmed, Inc. makes
Sounmed, Inc. manufactures colposcopes, including the Colpo-99 and Colpo-99Plus, and portable ultrasound scanners, such as the SD-2000 Plus. These devices are designed for gynecological examinations and imaging applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. Sounmed, Inc. is based in the United States.
Catalogue
Sounmed Coloposcope Colpo-99/99PLUS Ref K070845
Regimes: 510(k) Registry: 510(k)Sounmed Sd-2000 Plus Portable Ultrasound Scanner Ref K071156
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sounmed, Inc. have in the registry?
The registry currently lists 2 devices for Sounmed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sounmed, Inc.'s devices?
Among its 2 most recently registered devices, Sounmed, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sounmed, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sounmed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sounmed, Inc. in the registry?
The most recently registered devices listed for Sounmed, Inc. include SOUNMED COLOPOSCOPE COLPO-99/99PLUS and SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER.