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FDA 510(k), K152115, Renew NCP-5 External Counterpulsation System
FDA 510(k), K152115, Renew NCP-5 External Counterpulsation System
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510(K) Number: K152115
Device Name: Renew NCP-5 External Counterpulsation System
Manufacturer: Stage 2 Innovations
Device Classification Name: device, counter-pulsating, external
Regulation Number: 870.5225
Classification Product Code: DRN
Date Received: 07/29/2015
Decision Date: 12/17/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Renew NCP-5 External Counterpulsation System
Manufacturer: Stage 2 Innovations
Device Classification Name: device, counter-pulsating, external
Regulation Number: 870.5225
Classification Product Code: DRN
Date Received: 07/29/2015
Decision Date: 12/17/2015
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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