FDA 510(k), K162832, 731 Series Ventilators

FDA 510(k), K162832, 731 Series Ventilators

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510(K) Number: K162832
Device Name: 731 Series Ventilators
Manufacturer: CHUCK KOLIFRATH
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 10/11/2016
Decision Date: 08/02/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
  • 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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