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

    PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1

    K Number: K911104 · Decision Jun 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    18
    Review Days
    90

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    Basic Information

    Device Name
    PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
    K Number
    K911104
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hgm Medical Laser Systems, Inc.
    Date Received
    March 13, 1991
    Decision Date
    June 11, 1991
    Product Code
    FEX
    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
    FEX Instrument, Catheter, Punch

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