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FDA 510(k)

RESUSCITATOR VALVE ASSEMBLY W/FILTER

K-Number: K882204 · 1988-07-08

ApplicantIntertech/Ohio
Decision Date1988-07-08
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUSCITATOR VALVE ASSEMBLY W/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Intertech/Ohio. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K882204. 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 RESUSCITATOR VALVE ASSEMBLY W/FILTER?

RESUSCITATOR VALVE ASSEMBLY W/FILTER is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Intertech/Ohio. The 510(k) number is K882204.

When did RESUSCITATOR VALVE ASSEMBLY W/FILTER receive FDA 510(k) clearance?

RESUSCITATOR VALVE ASSEMBLY W/FILTER received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882204.

Who is the listed applicant for RESUSCITATOR VALVE ASSEMBLY W/FILTER?

The FDA 510(k) record lists Intertech/Ohio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUSCITATOR VALVE ASSEMBLY W/FILTER?

The FDA product code for RESUSCITATOR VALVE ASSEMBLY W/FILTER is CBP.

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Other records listing Intertech/Ohio 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.

K895144INTERTECH METERED DOSE ELBOWK890346INTERTECH UNIVERSAL HYDROPHOBIC FILTERK884525PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORTK884526ADULT RESUSCITATOR WITH MASK AND FILTERK880394FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATORK863033PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS

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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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