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FDA 510(k)

BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT

K-Number: K924671 · 1993-04-21

ApplicantEngineered Medical Systems
Decision Date1993-04-21
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 1993-04-21 under 510(k) number K924671. 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 BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT?

BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT is a medical device that received FDA 510(k) clearance on 1993-04-21. The listed applicant is Engineered Medical Systems. The 510(k) number is K924671.

When did BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT receive FDA 510(k) clearance?

BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT received FDA 510(k) clearance on 1993-04-21, under 510(k) number K924671.

Who is the listed applicant for BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT?

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

What is the FDA product code for BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT?

The FDA product code for BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT is BTM.

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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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