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

    FRASER HARLAKE EMERG. CARE SUCTION SYS

    K Number: K841903 · Decision Jun 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    9
    Review Days
    38

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    Basic Information

    Device Name
    FRASER HARLAKE EMERG. CARE SUCTION SYS
    K Number
    K841903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Fraser Harlake, Inc.
    Date Received
    May 7, 1984
    Decision Date
    June 14, 1984
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Fraser Harlake, Inc.

    K Number Device Name
    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.
    K822040 POWERED EMERGENCY VENTILATOR
    K821744 FRASER HARLAKE NITRONOX SCAVENGER
    K802943 POSITIVE END EXPIRATORY PRESSURE VALVE