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

    IQK-200

    K Number: K881313 · Decision May 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    5
    Review Days
    52

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    Basic Information

    Device Name
    IQK-200
    K Number
    K881313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Repackers Co.
    Date Received
    March 28, 1988
    Decision Date
    May 19, 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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    Other Clearances by Medical Repackers Co.

    K Number Device Name
    K890575 ACCUTHERM PTS-200
    K882977 ASK-300
    K881429 YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
    K874674 AIK-100 ANESTHESIA INDUCTION KIT/TRAY