Xandar Kardian, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What Xandar Kardian, Inc. makes
Xandar Kardian, Inc. manufactures a wireless vital sign monitoring sensor (Model XK300) designed to track physiological metrics such as heart rate and oxygen saturation for continuous patient monitoring.
The company’s product portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The sensor is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Vital Sign Monitoring Sensor (Model :XK300) Ref K202464
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xandar Kardian, Inc. have in the registry?
The registry currently lists 1 device for Xandar Kardian, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xandar Kardian, Inc.'s devices?
Among its 1 most recently registered device, Xandar Kardian, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Xandar Kardian, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Xandar Kardian, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xandar Kardian, Inc. in the registry?
The most recently registered devices listed for Xandar Kardian, Inc. include Vital Sign Monitoring Sensor (Model :XK300).