FDA 510(k)

MANUAL RESUSCITATOR

K-Number: K963848 · 1997-07-07

Decision Date1997-07-07

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Owens-Brigam Medical Co.. It received FDA 510(k) clearance on 1997-07-07 under 510(k) number K963848. 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 MANUAL RESUSCITATOR?

MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1997-07-07. The listed applicant is Owens-Brigam Medical Co.. The 510(k) number is K963848.

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

MANUAL RESUSCITATOR received FDA 510(k) clearance on 1997-07-07, under 510(k) number K963848.

Who is the listed applicant for MANUAL RESUSCITATOR?

The FDA 510(k) record lists Owens-Brigam Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL RESUSCITATOR?

The FDA product code for 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 Owens-Brigam Medical Co. as applicant

K952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE 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.