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FDA 510(k), K100528, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
FDA 510(k), K100528, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
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510(K) Number: K100528
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: 02/24/2010
Decision Date: 04/23/2010
Regulation Medical Specialty: Anesthesiology
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: 02/24/2010
Decision Date: 04/23/2010
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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