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: 10/06/2008
Date Received: 07/20/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology

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