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FDA 510(k)

GENUINE FIRST AID CPR MASK

K-Number: K112126 · 2011-12-01

ApplicantGenuine First Aid, LLC
Decision Date2011-12-01
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GENUINE FIRST AID CPR MASK is the device name listed in this FDA 510(k) record. The listed applicant is Genuine First Aid, LLC. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K112126. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENUINE FIRST AID CPR MASK?

GENUINE FIRST AID CPR MASK is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Genuine First Aid, LLC. The 510(k) number is K112126.

When did GENUINE FIRST AID CPR MASK receive FDA 510(k) clearance?

GENUINE FIRST AID CPR MASK received FDA 510(k) clearance on 2011-12-01, under 510(k) number K112126.

Who is the listed applicant for GENUINE FIRST AID CPR MASK?

The FDA 510(k) record lists Genuine First Aid, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENUINE FIRST AID CPR MASK?

The FDA product code for GENUINE FIRST AID CPR MASK is CBP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Genuine First Aid, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102299CPR FACE MASK

Related Devices (Code: CBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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