FDA 510(k), K130409, ALIVECOR HEART MONITOR
FDA 510(k), K130409, ALIVECOR HEART MONITOR
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510(K) Number: K130409
Device Name: ALIVECOR HEART MONITOR
Manufacturer: ALIVECOR, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 02/19/2013
Decision Date: 09/06/2013
Regulation Medical Specialty: Cardiovascular
Device Name: ALIVECOR HEART MONITOR
Manufacturer: ALIVECOR, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 02/19/2013
Decision Date: 09/06/2013
Regulation Medical Specialty: Cardiovascular
- 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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