BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT

    K Number: K884525 · Decision Dec 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
    K Number
    K884525
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    October 27, 1988
    Decision Date
    December 16, 1988
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

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