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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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