BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COAST VIDEO ENDOSCOPIC IMAGING SYSTEM

    K Number: K926166 · Decision Jun 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    COAST VIDEO ENDOSCOPIC IMAGING SYSTEM
    K Number
    K926166
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optik
    Date Received
    December 8, 1992
    Decision Date
    June 1, 1993
    Product Code
    FWF
    Advisory Committee
    General, Plastic Surgery
    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
    FWF Camera, Television, Endoscopic, Without Audio

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