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

    ECG SIMULATOR MODEL ECGPLUS

    K Number: K893660 · Decision Dec 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    37
    Review Days
    204

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    Basic Information

    Device Name
    ECG SIMULATOR MODEL ECGPLUS
    K Number
    K893660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    May 15, 1989
    Decision Date
    December 5, 1989
    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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