Oxiwear, Inc.
Country not established
- Devices
- 1
What Oxiwear, Inc. makes
Oxiwear, Inc. manufactures the OxiWear device, a wearable monitor designed to measure and track oxygen saturation levels in real time, primarily used for patient monitoring in clinical and home healthcare settings.
The OxiWear device is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
OxiWear Ref K233827
510(k) 510(k)GUDID
Company details
- DUNS number
- 117449472
Frequently asked questions
How many devices does Oxiwear, Inc. have in the registry?
The registry currently lists 1 device for Oxiwear, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oxiwear, Inc.'s devices?
Among its 1 most recently registered device, Oxiwear, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oxiwear, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oxiwear, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oxiwear, Inc. in the registry?
The most recently registered devices listed for Oxiwear, Inc. include OxiWear.