BREATHE NIOV VENTILATION SYSTEM— 510(k) K131562

Name: FDA 510(k) clearance K131562
Creator: U.S. Food and Drug Administration
Published: 2014-03-06

Substantially Equivalent

Breathe Technologies

FDA 510(k) clearance K131562 for BREATHE NIOV VENTILATION SYSTEM, Substantially Equivalent on 2014-03-06. Applicant: Breathe Technologies. Device class: 2.

Clearance details

Applicant: Breathe Technologies
Product code: Code ONZ
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2013-05-30
Decision date: 2014-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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