BigEasy Non-Rebreathing Valve— 510(k) K142402

Name: FDA 510(k) clearance K142402
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Substantially Equivalent

12th Man Technologies, Inc.

FDA 510(k) clearance K142402 for BigEasy Non-Rebreathing Valve, Substantially Equivalent on 2015-03-23. Applicant: 12th Man Technologies, Inc.. Device class: 2.

Clearance details

Applicant: 12th Man Technologies, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2014-08-27
Decision date: 2015-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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