FDA 510(k), K202464, Vital Sign Monitoring Sensor (Model :XK300)
FDA 510(k), K202464, Vital Sign Monitoring Sensor (Model :XK300)
510(K) Number: K202464
Device Name: Vital Sign Monitoring Sensor (Model :XK300)
Manufacturer: Xandar Kardian Inc.
Device Classification Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation Number: 870.2300
Classification Product Code: DRT
Date Received: 08/27/2020
Decision Date: 04/26/2021
Regulation Medical Specialty: Cardiovascular
Total pages: 1174
Fully redacted pages: 861
Content pages: 313
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