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FDA 510(k), K011046, AUTOPULSE, MODEL 100
FDA 510(k), K011046, AUTOPULSE, MODEL 100
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510(K) Number: K011046
Device Name: AUTOPULSE, MODEL 100
Manufacturer: REVIVANT CORP.
Device Classification Name: compressor, cardiac, external
Regulation Number: 870.5200
Classification Product Code: DRM
Date Received: 04/06/2001
Decision Date: 10/25/2001
Regulation Medical Specialty: Cardiovascular
Device Name: AUTOPULSE, MODEL 100
Manufacturer: REVIVANT CORP.
Device Classification Name: compressor, cardiac, external
Regulation Number: 870.5200
Classification Product Code: DRM
Date Received: 04/06/2001
Decision Date: 10/25/2001
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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