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FDA 510(k)

4-O2 JR. (CPR MOUTH BARRIER)

K-Number: K945177 · 1994-11-01

ApplicantEagle Health Supplies
Decision Date1994-11-01
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4-O2 JR. (CPR MOUTH BARRIER) is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Health Supplies. It received FDA 510(k) clearance on 1994-11-01 under 510(k) number K945177. 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 4-O2 JR. (CPR MOUTH BARRIER)?

4-O2 JR. (CPR MOUTH BARRIER) is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is Eagle Health Supplies. The 510(k) number is K945177.

When did 4-O2 JR. (CPR MOUTH BARRIER) receive FDA 510(k) clearance?

4-O2 JR. (CPR MOUTH BARRIER) received FDA 510(k) clearance on 1994-11-01, under 510(k) number K945177.

Who is the listed applicant for 4-O2 JR. (CPR MOUTH BARRIER)?

The FDA 510(k) record lists Eagle Health Supplies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4-O2 JR. (CPR MOUTH BARRIER)?

The FDA product code for 4-O2 JR. (CPR MOUTH BARRIER) 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.

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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

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

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