Hypermed, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hypermed, Inc. makes
Hypermed, Inc. manufactures hyperspectral tissue oxygenation measurement systems, including the OXY VU1 and OXYVU-1 models. These devices are designed to assess tissue oxygenation levels using hyperspectral imaging technology, supporting clinical monitoring and diagnostic evaluations.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These systems are intended for use in the United States, where they are subject to compliance with FDA requirements for medical device authorisation.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hypermed, Inc. have in the registry?
The registry currently lists 2 devices for Hypermed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hypermed, Inc.'s devices?
Among its 2 most recently registered devices, Hypermed, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hypermed, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hypermed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hypermed, Inc. in the registry?
The most recently registered devices listed for Hypermed, Inc. include HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 and OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM.