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

    MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6

    K Number: K040244 · Decision Mar 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
    K Number
    K040244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Microoptical Corporation
    Date Received
    February 3, 2004
    Decision Date
    March 24, 2004
    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 The Microoptical Corporation

    K Number Device Name
    K042923 MD-6W WIRELESS CRITICAL DATA VIEWER