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FDA 510(k), K151188, BodyGuardian Remote Monitoring System
FDA 510(k), K151188, BodyGuardian Remote Monitoring System
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510(K) Number: K151188
Device Name: BodyGuardian Remote Monitoring System
Manufacturer: CHARLIE RECTOR
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 05/04/2015
Decision Date: 09/17/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BodyGuardian Remote Monitoring System
Manufacturer: CHARLIE RECTOR
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 05/04/2015
Decision Date: 09/17/2015
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
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