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

    HUMIDIFIER, DISPOSABLE

    K Number: K760372 · Decision Aug 13, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    1
    Review Days
    8

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    Basic Information

    Device Name
    HUMIDIFIER, DISPOSABLE
    K Number
    K760372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hospitek
    Date Received
    August 5, 1976
    Decision Date
    August 13, 1976
    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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