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FDA 510(k)

STURDY MANUAL RESUSCITATOR

K-Number: K032596 · 2004-08-05

ApplicantSturdy Industrial Co., Ltd.
Decision Date2004-08-05
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STURDY MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sturdy Industrial Co., Ltd.. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K032596. 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 STURDY MANUAL RESUSCITATOR?

STURDY MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Sturdy Industrial Co., Ltd.. The 510(k) number is K032596.

When did STURDY MANUAL RESUSCITATOR receive FDA 510(k) clearance?

STURDY MANUAL RESUSCITATOR received FDA 510(k) clearance on 2004-08-05, under 510(k) number K032596.

Who is the listed applicant for STURDY MANUAL RESUSCITATOR?

The FDA 510(k) record lists Sturdy Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STURDY MANUAL RESUSCITATOR?

The FDA product code for STURDY MANUAL 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 Sturdy Industrial Co., Ltd. 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.

K231489Sturdy Autoclave Super MicromK181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

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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