FDA 510(k), K161772, FFRct
FDA 510(k), K161772, FFRct
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510(K) Number: K161772
Device Name: FFRct
Manufacturer: Windi Hary
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: PJA
Classification Product Code: 06/28/2016
Date Received: 08/24/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: FFRct
Manufacturer: Windi Hary
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: PJA
Classification Product Code: 06/28/2016
Date Received: 08/24/2016
Decision Date: Substantially Equivalent (SESE)
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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