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FDA 510(k), K201881, CoroFlow Cardiovascular System
FDA 510(k), K201881, CoroFlow Cardiovascular System
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$149.00 USD
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510(K) Number: K201881
Device Name: CoroFlow Cardiovascular System
Manufacturer: Coroventis Research AB
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 07/07/2020
Decision Date: 11/13/2020
Regulation Medical Specialty: Cardiovascular
Device Name: CoroFlow Cardiovascular System
Manufacturer: Coroventis Research AB
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 07/07/2020
Decision Date: 11/13/2020
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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