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FDA 510(k)

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR

K-Number: K981307 · 1998-07-06

ApplicantInternational Respiratory Systems, Inc.
Decision Date1998-07-06
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR is the device name listed in this FDA 510(k) record. The listed applicant is International Respiratory Systems, Inc.. It received FDA 510(k) clearance on 1998-07-06 under 510(k) number K981307. 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 INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR?

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is International Respiratory Systems, Inc.. The 510(k) number is K981307.

When did INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR receive FDA 510(k) clearance?

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR received FDA 510(k) clearance on 1998-07-06, under 510(k) number K981307.

Who is the listed applicant for INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR?

The FDA 510(k) record lists International Respiratory Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR?

The FDA product code for INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR 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 International Respiratory Systems, 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.

K981308INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAGK923618PEEP VALVE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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