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

    NEOTECH MECONIUM ASPIRATOR (STERILE)

    K Number: K880487 · Decision May 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    6
    Review Days
    92

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    Basic Information

    Device Name
    NEOTECH MECONIUM ASPIRATOR (STERILE)
    K Number
    K880487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Neotech Products, Inc.
    Date Received
    February 4, 1988
    Decision Date
    May 6, 1988
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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