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FDA 510(k)

RESUS-AID DISPOSABLE RESUSCITATION SHIELD

K-Number: K852096 · 1985-07-08

ApplicantEmergency Situation Products
Decision Date1985-07-08
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUS-AID DISPOSABLE RESUSCITATION SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Emergency Situation Products. It received FDA 510(k) clearance on 1985-07-08 under 510(k) number K852096. 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 RESUS-AID DISPOSABLE RESUSCITATION SHIELD?

RESUS-AID DISPOSABLE RESUSCITATION SHIELD is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Emergency Situation Products. The 510(k) number is K852096.

When did RESUS-AID DISPOSABLE RESUSCITATION SHIELD receive FDA 510(k) clearance?

RESUS-AID DISPOSABLE RESUSCITATION SHIELD received FDA 510(k) clearance on 1985-07-08, under 510(k) number K852096.

Who is the listed applicant for RESUS-AID DISPOSABLE RESUSCITATION SHIELD?

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

What is the FDA product code for RESUS-AID DISPOSABLE RESUSCITATION SHIELD?

The FDA product code for RESUS-AID DISPOSABLE RESUSCITATION SHIELD 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 Emergency Situation Products 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.

K852095ESP EMERGENCY CARE KIT

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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