BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S— 510(k) K100528

Name: FDA 510(k) clearance K100528
Creator: U.S. Food and Drug Administration
Published: 2010-04-23

Substantially Equivalent

Breathe Technologies, Inc.

FDA 510(k) clearance K100528 for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S, Substantially Equivalent on 2010-04-23. Applicant: Breathe Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Breathe Technologies, Inc.
Product code: Code ONZ
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2010-02-24
Decision date: 2010-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

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