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

    AUTOMATIC TRAY (ACT I & ACT II

    K Number: K820117 · Decision Feb 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    31

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AUTOMATIC TRAY (ACT I & ACT II
    K Number
    K820117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1860
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Burbury & Cutter Ind., Inc.
    Date Received
    January 18, 1982
    Decision Date
    February 18, 1982
    Product Code
    KPX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPX Changer, Radiographic Film/Cassette

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KPX), ordered by most recent decision date.

    TRANS X-1000

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BCM-600TX

    FDA 510(k)
    FDA Class 2 ·Radiology

    BUCKYMATIC AUTOMATIC CHEST FILM CHANGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MWX-7440 HIGH SPEED BUCKY

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all