Surface Mount Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Surface Mount Technology, Inc. makes
Surface Mount Technology, Inc. manufactures the Electronic Glove Integrity Monitor (EGIM), a device designed to assess the structural integrity of electronic gloves, and the Sustained Phonation system, which supports voice function assessment or rehabilitation.
The company’s portfolio consists of Class I devices, all of which are listed via the FDA’s 510(k) pathway. These products are regulated under U.S. medical device laws and are based in the United States.
Catalogue
Electronic Glove Integrity Monitor (Egim) Ref K932714
Regimes: 510(k) Registry: 510(k)Sustained Phonation Ref K962961
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surface Mount Technology, Inc. have in the registry?
The registry currently lists 2 devices for Surface Mount Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surface Mount Technology, Inc.'s devices?
Among its 2 most recently registered devices, Surface Mount Technology, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Surface Mount Technology, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Surface Mount Technology, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Surface Mount Technology, Inc. in the registry?
The most recently registered devices listed for Surface Mount Technology, Inc. include ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) and SUSTAINED PHONATION.