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FDA 510(k)

MOUTH TO MOUTH BREATHER

K-Number: K942021 · 1994-06-22

ApplicantGam Industries, Inc.
Decision Date1994-06-22
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTH TO MOUTH BREATHER is the device name listed in this FDA 510(k) record. The listed applicant is Gam Industries, Inc.. It received FDA 510(k) clearance on 1994-06-22 under 510(k) number K942021. 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 MOUTH TO MOUTH BREATHER?

MOUTH TO MOUTH BREATHER is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Gam Industries, Inc.. The 510(k) number is K942021.

When did MOUTH TO MOUTH BREATHER receive FDA 510(k) clearance?

MOUTH TO MOUTH BREATHER received FDA 510(k) clearance on 1994-06-22, under 510(k) number K942021.

Who is the listed applicant for MOUTH TO MOUTH BREATHER?

The FDA 510(k) record lists Gam Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTH TO MOUTH BREATHER?

The FDA product code for MOUTH TO MOUTH BREATHER is CBP.

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Other records listing Gam Industries, Inc. 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.

K941641DISPOSABLE EMERGENCY OBSTETRICAL KITK941336COMBO MASKK936050JAW SPREADERK930401ALUMINUM FOILK926290BURN SHEETK925590MULTI-TRAUMA DRESSING

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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

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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