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FDA 510(k), K202464, Vital Sign Monitoring Sensor (Model :XK300)
FDA 510(k), K202464, Vital Sign Monitoring Sensor (Model :XK300)
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$149.00 USD
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$149.00 USD
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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