FDA 510(k), K161772, FFRct

FDA 510(k), K161772, FFRct

Regular price $149.00 USD
Regular price Sale price $149.00 USD
Sale Sold out
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

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.

View full details