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

    LP-3 ELECTROCARDIOGRAPH

    K Number: K864614 · Decision Jun 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    8
    Review Days
    204

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    Basic Information

    Device Name
    LP-3 ELECTROCARDIOGRAPH
    K Number
    K864614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fidelity Medical, Inc.
    Date Received
    November 24, 1986
    Decision Date
    June 16, 1987
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Fidelity Medical, Inc.

    K Number Device Name
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    K942504 INSTASPOT
    K941917 FLUOROPLUA CARDIAC AND/OR INSTAVIEW
    K903774 LP-PLUS
    K872928 LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
    K841780 CLINICAL ELECTRONIC THERMOMETER