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FDA 510(k)

POSITIVE END EXPIRATORY PRESSURE VALVE

K-Number: K802943 · 1981-01-15

ApplicantFraser Harlake, Inc.
Decision Date1981-01-15
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POSITIVE END EXPIRATORY PRESSURE VALVE 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 1981-01-15 under 510(k) number K802943. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POSITIVE END EXPIRATORY PRESSURE VALVE?

POSITIVE END EXPIRATORY PRESSURE VALVE is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is Fraser Harlake, Inc.. The 510(k) number is K802943.

When did POSITIVE END EXPIRATORY PRESSURE VALVE receive FDA 510(k) clearance?

POSITIVE END EXPIRATORY PRESSURE VALVE received FDA 510(k) clearance on 1981-01-15, under 510(k) number K802943.

Who is the listed applicant for POSITIVE END EXPIRATORY PRESSURE VALVE?

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 POSITIVE END EXPIRATORY PRESSURE VALVE?

The FDA product code for POSITIVE END EXPIRATORY PRESSURE VALVE is BYE.

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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: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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