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FDA 510(k)

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX

K-Number: K014115 · 2002-02-27

ApplicantPortex, Inc.
Decision Date2002-02-27
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 2002-02-27 under 510(k) number K014115. 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 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX?

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX is a medical device that received FDA 510(k) clearance on 2002-02-27. The listed applicant is Portex, Inc.. The 510(k) number is K014115.

When did 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX receive FDA 510(k) clearance?

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX received FDA 510(k) clearance on 2002-02-27, under 510(k) number K014115.

Who is the listed applicant for 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX?

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

What is the FDA product code for 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX?

The FDA product code for 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX is BTM.

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Other records listing Portex, 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.

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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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