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

    MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER

    K Number: K860435 · Decision May 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
    K Number
    K860435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Multigon Industries, Inc.
    Date Received
    February 4, 1986
    Decision Date
    May 5, 1986
    Product Code
    DPT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPT Probe, Blood-Flow, Extravascular

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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
    K882755 MODEL 500V VASCULAR SPECTRUM ANALYZER
    K863589 MODEL 600 VASCULAR DUPLEX IMAGER
    K852680 TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG