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

    SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM

    K Number: K943593 · Decision Mar 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    240

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    Basic Information

    Device Name
    SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
    K Number
    K943593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ovamed Corp.
    Date Received
    July 25, 1994
    Decision Date
    March 22, 1995
    Product Code
    ODF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODF Mini Endoscope, Gastroenterology-Urology

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