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FDA 510(k)

BAUMAN CPR/RESPIRATOR

K-Number: K864308 · 1987-03-09

ApplicantGeneral Medical Products, Inc.
Decision Date1987-03-09
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAUMAN CPR/RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Products, Inc.. It received FDA 510(k) clearance on 1987-03-09 under 510(k) number K864308. 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 BAUMAN CPR/RESPIRATOR?

BAUMAN CPR/RESPIRATOR is a medical device that received FDA 510(k) clearance on 1987-03-09. The listed applicant is General Medical Products, Inc.. The 510(k) number is K864308.

When did BAUMAN CPR/RESPIRATOR receive FDA 510(k) clearance?

BAUMAN CPR/RESPIRATOR received FDA 510(k) clearance on 1987-03-09, under 510(k) number K864308.

Who is the listed applicant for BAUMAN CPR/RESPIRATOR?

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

What is the FDA product code for BAUMAN CPR/RESPIRATOR?

The FDA product code for BAUMAN CPR/RESPIRATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Medical Products, 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.

K904346BAUMAN CPR/RESUSCITATOR

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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