BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FRASER HARLAKE HOPE III RESUSCITATOR

    K Number: K841496 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    FRASER HARLAKE HOPE III RESUSCITATOR
    K Number
    K841496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Harlake, Inc.
    Date Received
    April 10, 1984
    Decision Date
    April 24, 1984
    Product Code
    BTM
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Fraser Harlake, Inc.

    K Number Device Name
    K841903 FRASER HARLAKE EMERG. CARE SUCTION SYS
    K833799 SPHYGOMANO METER
    K833692 FRASER HARLAKE DENTAL ANTI-POLUTION SYS
    K833151 BOYLE SYSTEM ANESTHESIA GAS MACHINE
    K831427 CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
    K822040 POWERED EMERGENCY VENTILATOR
    K821744 FRASER HARLAKE NITRONOX SCAVENGER
    K802943 POSITIVE END EXPIRATORY PRESSURE VALVE