FDA 510(k)

BAWMED E-Z BAG RESUSCITATOR

K-Number: K031434 · 2004-02-06

Decision Date2004-02-06

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BAWMED E-Z BAG RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bawmed UK. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K031434. 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 BAWMED E-Z BAG RESUSCITATOR?

BAWMED E-Z BAG RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Bawmed UK. The 510(k) number is K031434.

When did BAWMED E-Z BAG RESUSCITATOR receive FDA 510(k) clearance?

BAWMED E-Z BAG RESUSCITATOR received FDA 510(k) clearance on 2004-02-06, under 510(k) number K031434.

Who is the listed applicant for BAWMED E-Z BAG RESUSCITATOR?

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

What is the FDA product code for BAWMED E-Z BAG RESUSCITATOR?

The FDA product code for BAWMED E-Z BAG RESUSCITATOR is BTM.

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Other records listing Bawmed UK as applicant

K031431BAWMED RESCUE MASK

Related Devices (Code: BTM)

K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS K243861butterflyBVMCompact Medical, Inc.K221841EOlife®Archeon K212905Sotair DeviceSafe Bvm Corporation K210288Disposable 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.