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

    SONY DXC-LS1 COLOR VIDEO CAMERA

    K Number: K980279 · Decision Apr 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    88

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    Basic Information

    Device Name
    SONY DXC-LS1 COLOR VIDEO CAMERA
    K Number
    K980279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sony Medical Electronics Co.
    Date Received
    January 26, 1998
    Decision Date
    April 24, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Sony Medical Electronics Co.

    K Number Device Name
    K913886 SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER
    K904447 SONY CINE VIDEO SYSTEM SME-3500
    K902535 SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM
    K901153 SONY VO-5800H VIDEOCASSETTE RECORDER
    K885042 SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD
    K884008 SONY CINE VIDEO SYSTEM SME-3300
    K882958 SONY VIDEO PRINTERS, UP SERIES