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

    DEL MAR AVIONICS 8300 SECTOR IMAGER SYS

    K Number: K844896 · Decision Jun 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    54
    Review Days
    175

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    Basic Information

    Device Name
    DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
    K Number
    K844896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Del Mar Avionics
    Date Received
    December 17, 1984
    Decision Date
    June 10, 1985
    Product Code
    DXK
    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
    DXK Echocardiograph

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    Other Clearances by Del Mar Avionics

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    K950020 HOLTER PACERCORDER(R)
    K942653 HOLTER SSR DIGICORDER(TM)
    K922221 SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
    K896862 MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
    K895793 MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
    K894543 MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
    K891148 MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
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