BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)— 510(k) K103345

Name: FDA 510(k) clearance K103345
Creator: U.S. Food and Drug Administration
Published: 2011-02-11

Substantially Equivalent

Breathe Technologies, Inc.

FDA 510(k) clearance K103345 for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S), Substantially Equivalent on 2011-02-11. 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: 2010-11-15
Decision date: 2011-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONZ

view all

K152664 — TAV System2016-12-02
K131562 — BREATHE NIOV VENTILATION SYSTEM2014-03-06
K102525 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)2010-12-02
K100528 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S2010-04-23
K082982 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES2009-07-20

More clearances from Breathe Technologies, Inc.

view all

K130037 — BREATHE CPAP SYSTEM2013-05-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.