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

    COMBISON(R) 311

    K Number: K925354 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    COMBISON(R) 311
    K Number
    K925354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kretztechnik AG
    Date Received
    October 22, 1992
    Decision Date
    July 8, 1993
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Kretztechnik AG

    K Number Device Name
    K904070 COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A
    K910966 SECTOR TRANSDUCER MODEL NO. AWP3.5/A
    K904665 MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
    K901725 ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
    K901655 1 TRANSDUCER FOR COMBISON 310A