BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES— 510(k) K082982

Name: FDA 510(k) clearance K082982
Creator: U.S. Food and Drug Administration
Published: 2009-07-20

Substantially Equivalent

Breathe Technologies, Inc.

FDA 510(k) clearance K082982 for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES, Substantially Equivalent on 2009-07-20. 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: 2008-10-06
Decision date: 2009-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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