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FDA 510(k), K062093, AVEA VENTILATOR
FDA 510(k), K062093, AVEA VENTILATOR
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510(K) Number: K062093
Device Name: AVEA VENTILATOR
Manufacturer: TOM GUTIERREZ
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: 07/24/2006
Date Received: 09/20/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: AVEA VENTILATOR
Manufacturer: TOM GUTIERREZ
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: 07/24/2006
Date Received: 09/20/2006
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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