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

    SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER

    K Number: K913886 · Decision Jan 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    8
    Review Days
    148

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    Basic Information

    Device Name
    SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER
    K Number
    K913886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sony Medical Electronics Co.
    Date Received
    August 29, 1991
    Decision Date
    January 24, 1992
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Sony Medical Electronics Co.

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    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