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FDA 510(k), K082982, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
FDA 510(k), K082982, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
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510(K) Number: K082982
Device Name: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
Manufacturer: CRAIG COOMBS
Device Classification Name: Mechanical Ventilator
Regulation Number: ONZ
Classification Product Code: KXA
Date Received: 10/06/2008
Decision Date: 07/20/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
Manufacturer: CRAIG COOMBS
Device Classification Name: Mechanical Ventilator
Regulation Number: ONZ
Classification Product Code: KXA
Date Received: 10/06/2008
Decision Date: 07/20/2009
Decision: 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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