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FDA 510(k)

ADULT RESUSCITATOR WITH MASK AND FILTER

K-Number: K884526 · 1988-11-16

ApplicantIntertech/Ohio
Decision Date1988-11-16
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ADULT RESUSCITATOR WITH MASK AND 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 1988-11-16 under 510(k) number K884526. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADULT RESUSCITATOR WITH MASK AND FILTER?

ADULT RESUSCITATOR WITH MASK AND FILTER is a medical device that received FDA 510(k) clearance on 1988-11-16. The listed applicant is Intertech/Ohio. The 510(k) number is K884526.

When did ADULT RESUSCITATOR WITH MASK AND FILTER receive FDA 510(k) clearance?

ADULT RESUSCITATOR WITH MASK AND FILTER received FDA 510(k) clearance on 1988-11-16, under 510(k) number K884526.

Who is the listed applicant for ADULT RESUSCITATOR WITH MASK AND 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 ADULT RESUSCITATOR WITH MASK AND FILTER?

The FDA product code for ADULT RESUSCITATOR WITH MASK AND FILTER is BTM.

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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 PORTK882204RESUSCITATOR VALVE ASSEMBLY W/FILTERK880394FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATORK863033PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS

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Related Devices (Code: BTM)

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.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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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