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

    POWERED EMERGENCY VENTILATOR

    K Number: K822040 · Decision Aug 19, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    38

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    Basic Information

    Device Name
    POWERED EMERGENCY VENTILATOR
    K Number
    K822040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Harlake, Inc.
    Date Received
    July 12, 1982
    Decision Date
    August 19, 1982
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Fraser Harlake, Inc.

    K Number Device Name
    K841903 FRASER HARLAKE EMERG. CARE SUCTION SYS
    K833799 SPHYGOMANO METER
    K841496 FRASER HARLAKE HOPE III RESUSCITATOR
    K833692 FRASER HARLAKE DENTAL ANTI-POLUTION SYS
    K833151 BOYLE SYSTEM ANESTHESIA GAS MACHINE
    K831427 CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
    K821744 FRASER HARLAKE NITRONOX SCAVENGER
    K802943 POSITIVE END EXPIRATORY PRESSURE VALVE