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FDA 510(k)

RESPOSABLE RESUSCITATOR

K-Number: K953617 · 1995-11-22

ApplicantMedical Marketing Concepts
Decision Date1995-11-22
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPOSABLE RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Marketing Concepts. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K953617. 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 RESPOSABLE RESUSCITATOR?

RESPOSABLE RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Medical Marketing Concepts. The 510(k) number is K953617.

When did RESPOSABLE RESUSCITATOR receive FDA 510(k) clearance?

RESPOSABLE RESUSCITATOR received FDA 510(k) clearance on 1995-11-22, under 510(k) number K953617.

Who is the listed applicant for RESPOSABLE RESUSCITATOR?

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

What is the FDA product code for RESPOSABLE RESUSCITATOR?

The FDA product code for RESPOSABLE RESUSCITATOR is BTM.

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.

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Other records listing Medical Marketing Concepts 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.

K982215MANUAL RESUSCITATOR WITH ACEK961867PEEP VALVEK961329BAGRIGHT CHILD RESUSCITATORK961330BAGRIGHT INFANT RESUSCITATORK961868RESPOSABLE CHILD RESUSCITATORK961369BAGRIGHT RESPOSABLE RESUSCITATOR

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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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