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FDA 510(k)

FRASER HARLAKE HOPE III RESUSCITATOR

K-Number: K841496 · 1984-04-24

ApplicantFraser Harlake, Inc.
Decision Date1984-04-24
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FRASER HARLAKE HOPE III RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fraser Harlake, Inc.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K841496. 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 FRASER HARLAKE HOPE III RESUSCITATOR?

FRASER HARLAKE HOPE III RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Fraser Harlake, Inc.. The 510(k) number is K841496.

When did FRASER HARLAKE HOPE III RESUSCITATOR receive FDA 510(k) clearance?

FRASER HARLAKE HOPE III RESUSCITATOR received FDA 510(k) clearance on 1984-04-24, under 510(k) number K841496.

Who is the listed applicant for FRASER HARLAKE HOPE III RESUSCITATOR?

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

What is the FDA product code for FRASER HARLAKE HOPE III RESUSCITATOR?

The FDA product code for FRASER HARLAKE HOPE III RESUSCITATOR is BTM.

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Other records listing Fraser Harlake, 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.

K841903FRASER HARLAKE EMERG. CARE SUCTION SYSK833799SPHYGOMANO METERK833692FRASER HARLAKE DENTAL ANTI-POLUTION SYSK833151BOYLE SYSTEM ANESTHESIA GAS MACHINEK831427CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.K822040POWERED EMERGENCY VENTILATOR

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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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