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FDA 510(k)

POWERED EMERGENCY VENTILATOR

K-Number: K822040 · 1982-08-19

ApplicantFraser Harlake, Inc.
Decision Date1982-08-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POWERED EMERGENCY VENTILATOR 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 1982-08-19 under 510(k) number K822040. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED EMERGENCY VENTILATOR?

POWERED EMERGENCY VENTILATOR is a medical device that received FDA 510(k) clearance on 1982-08-19. The listed applicant is Fraser Harlake, Inc.. The 510(k) number is K822040.

When did POWERED EMERGENCY VENTILATOR receive FDA 510(k) clearance?

POWERED EMERGENCY VENTILATOR received FDA 510(k) clearance on 1982-08-19, under 510(k) number K822040.

Who is the listed applicant for POWERED EMERGENCY VENTILATOR?

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 POWERED EMERGENCY VENTILATOR?

The FDA product code for POWERED EMERGENCY VENTILATOR is CBK.

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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 METERK841496FRASER HARLAKE HOPE III RESUSCITATORK833692FRASER HARLAKE DENTAL ANTI-POLUTION SYSK833151BOYLE SYSTEM ANESTHESIA GAS MACHINEK831427CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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