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

    LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL

    K Number: K870173 · Decision Apr 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL
    K Number
    K870173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mauna Loa Medical, Inc.
    Date Received
    January 14, 1987
    Decision Date
    April 3, 1987
    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 Mauna Loa Medical, Inc.

    K Number Device Name
    K904538 MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT