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

Substantially Equivalent

Breathe Technologies, Inc.

FDA 510(k) clearance K102525 for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S), Substantially Equivalent on 2010-12-02. Applicant: Breathe Technologies, Inc..

Clearance details

Applicant: Breathe Technologies, Inc.
Product code: Code ONZ
Advisory panel: Anesthesiology
Date received: 2010-09-02
Decision date: 2010-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

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