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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004

    K Number: K062664 · Decision Dec 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    30
    Review Days
    90

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    Basic Information

    Device Name
    HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
    K Number
    K062664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apex Medical Corp.
    Date Received
    September 7, 2006
    Decision Date
    December 6, 2006
    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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