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FDA 510(k)

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC

K-Number: K952169 · 1995-06-08

ApplicantIntertech Resources, Inc.
Decision Date1995-06-08
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC is the device name listed in this FDA 510(k) record. The listed applicant is Intertech Resources, Inc.. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K952169. 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 SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC?

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K952169.

When did SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC receive FDA 510(k) clearance?

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC received FDA 510(k) clearance on 1995-06-08, under 510(k) number K952169.

Who is the listed applicant for SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC?

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

What is the FDA product code for SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC?

The FDA product code for SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC is BTM.

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Other records listing Intertech Resources, 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.

K9613181ST RESPONSE DISPOSABLE MANOMETERK955008HEAT & MOISTURE EXCHANGERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952062PFT FILTERK952214SIMS INTERTECH HYPERINFLATION BAG SYSTEM

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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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