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FDA 510(k), K030656, ENVAN HEART RATE MONITOR
FDA 510(k), K030656, ENVAN HEART RATE MONITOR
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510(K) Number: K030656
Device Name: ENVAN HEART RATE MONITOR
Manufacturer: ENVAN, LLC
Device Classification Name: monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Number: 870.2300
Classification Product Code: DRT
Date Received: 03/03/2003
Decision Date: 04/08/2003
Regulation Medical Specialty: Cardiovascular
Device Name: ENVAN HEART RATE MONITOR
Manufacturer: ENVAN, LLC
Device Classification Name: monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Number: 870.2300
Classification Product Code: DRT
Date Received: 03/03/2003
Decision Date: 04/08/2003
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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