FDA 510(k), K102525, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

FDA 510(k), K102525, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

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510(K) Number: K102525
Device Name: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
Manufacturer: BREATHE TECHNOLOGIES, INC.
Device Classification Name: mechanical ventilator
Regulation Number: 868.5895
Classification Product Code: ONZ
Date Received: 09/02/2010
Decision Date: 12/02/2010
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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