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

    RESP. AIR TEMP. CONTROL & HAZARD MON.

    K Number: K761295 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    9

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    Basic Information

    Device Name
    RESP. AIR TEMP. CONTROL & HAZARD MON.
    K Number
    K761295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Harris-Lake, Inc.
    Date Received
    December 21, 1976
    Decision Date
    December 30, 1976
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Harris-Lake, Inc.

    K Number Device Name
    K761293 RESPIRATORY HUMIDIFIER
    K761294 RESPIRATORY BLOWER
    K760333 JAR, COLLECTOR FOR SUCTION SYSTEMS
    K760314 FLOWMETER, OXYGEN
    K760316 REGULATORS, LOW SUCTION
    K760317 REGULATORS, HIGH SUCTION