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FDA 510(k)

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR

K-Number: K913474 · 1993-02-03

ApplicantMed-Tek Innovations, Inc.
Decision Date1993-02-03
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tek Innovations, Inc.. It received FDA 510(k) clearance on 1993-02-03 under 510(k) number K913474. 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 RESPIRE DISPOSABLE PULMONARY RESUSCITATOR?

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1993-02-03. The listed applicant is Med-Tek Innovations, Inc.. The 510(k) number is K913474.

When did RESPIRE DISPOSABLE PULMONARY RESUSCITATOR receive FDA 510(k) clearance?

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR received FDA 510(k) clearance on 1993-02-03, under 510(k) number K913474.

Who is the listed applicant for RESPIRE DISPOSABLE PULMONARY RESUSCITATOR?

The FDA 510(k) record lists Med-Tek Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRE DISPOSABLE PULMONARY RESUSCITATOR?

The FDA product code for RESPIRE DISPOSABLE PULMONARY 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 Med-Tek Innovations, 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.

K944194DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HMEK905288ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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