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

    MODEL 500V VASCULAR SPECTRUM ANALYZER

    K Number: K882755 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    147

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    Basic Information

    Device Name
    MODEL 500V VASCULAR SPECTRUM ANALYZER
    K Number
    K882755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Multigon Industries, Inc.
    Date Received
    July 5, 1988
    Decision Date
    November 29, 1988
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Multigon Industries, Inc.

    K Number Device Name
    K052067 DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
    K051739 POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
    K912044 MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
    K881263 MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
    K863589 MODEL 600 VASCULAR DUPLEX IMAGER
    K860435 MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
    K852680 TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG