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FDA 510(k)

EMS MOUTH TO MASK RESUSCITATORS

K-Number: K983919 · 1999-04-07

ApplicantEngineered Medical Systems
Decision Date1999-04-07
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMS MOUTH TO MASK RESUSCITATORS is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 1999-04-07 under 510(k) number K983919. 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 EMS MOUTH TO MASK RESUSCITATORS?

EMS MOUTH TO MASK RESUSCITATORS is a medical device that received FDA 510(k) clearance on 1999-04-07. The listed applicant is Engineered Medical Systems. The 510(k) number is K983919.

When did EMS MOUTH TO MASK RESUSCITATORS receive FDA 510(k) clearance?

EMS MOUTH TO MASK RESUSCITATORS received FDA 510(k) clearance on 1999-04-07, under 510(k) number K983919.

Who is the listed applicant for EMS MOUTH TO MASK RESUSCITATORS?

The FDA 510(k) record lists Engineered Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS MOUTH TO MASK RESUSCITATORS?

The FDA product code for EMS MOUTH TO MASK RESUSCITATORS is CBP.

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Other records listing Engineered Medical Systems 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.

K023683MULTI-STRAP FULL FACE MASKK013728TRACH VOXK013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013123EMS PULMONARY FUNCTION TESTING FILTERK013089EMS HEPA FILTER AND HME COMBINATIONSK003497DISPOSABLE PRESSURE MONITOR

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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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