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

    RESPIRATORY HUMIDIFIER

    K Number: K761293 · Decision Jan 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    7
    Review Days
    13

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    Basic Information

    Device Name
    RESPIRATORY HUMIDIFIER
    K Number
    K761293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Harris-Lake, Inc.
    Date Received
    December 21, 1976
    Decision Date
    January 3, 1977
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Harris-Lake, Inc.

    K Number Device Name
    K761294 RESPIRATORY BLOWER
    K761295 RESP. AIR TEMP. CONTROL & HAZARD MON.
    K760333 JAR, COLLECTOR FOR SUCTION SYSTEMS
    K760314 FLOWMETER, OXYGEN
    K760316 REGULATORS, LOW SUCTION
    K760317 REGULATORS, HIGH SUCTION