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FDA 510(k), K192732, BodyGuardian Remote Monitoring System
FDA 510(k), K192732, BodyGuardian Remote Monitoring System
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510(K) Number: K192732
Device Name: BodyGuardian Remote Monitoring System
Manufacturer: Charles Rector
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 09/27/2019
Decision Date: 03/26/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BodyGuardian Remote Monitoring System
Manufacturer: Charles Rector
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 09/27/2019
Decision Date: 03/26/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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