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

    DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER

    K Number: K861023 · Decision Nov 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    244

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    Basic Information

    Device Name
    DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER
    K Number
    K861023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Electronics Corp.
    Date Received
    March 18, 1986
    Decision Date
    November 17, 1986
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Diagnostic Electronics Corp.

    K Number Device Name
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    K830628 REAL-TIME SPECTRUM ANALYZER