GENUINE FIRST AID CPR MASK— 510(k) K112126

Name: FDA 510(k) clearance K112126
Creator: U.S. Food and Drug Administration
Published: 2011-12-01

Substantially Equivalent

Genuine First Aid, LLC

FDA 510(k) clearance K112126 for GENUINE FIRST AID CPR MASK, Substantially Equivalent on 2011-12-01. Applicant: Genuine First Aid, LLC. Device class: 2.

Clearance details

Applicant: Genuine First Aid, LLC
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2011-07-25
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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