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