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FDA 510(k)

MOUTH-TO-MASK RESUSCITATOR

K-Number: K940503 · 1995-03-23

ApplicantMtm Health Products , Ltd.
Decision Date1995-03-23
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTH-TO-MASK RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mtm Health Products , Ltd.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K940503. 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-MASK RESUSCITATOR?

MOUTH-TO-MASK RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Mtm Health Products , Ltd.. The 510(k) number is K940503.

When did MOUTH-TO-MASK RESUSCITATOR receive FDA 510(k) clearance?

MOUTH-TO-MASK RESUSCITATOR received FDA 510(k) clearance on 1995-03-23, under 510(k) number K940503.

Who is the listed applicant for MOUTH-TO-MASK RESUSCITATOR?

The FDA 510(k) record lists Mtm Health Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTH-TO-MASK RESUSCITATOR?

The FDA product code for MOUTH-TO-MASK RESUSCITATOR 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 Mtm Health Products , Ltd. 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.

K941008COMPLETE CPR KIT

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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