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

    COMPUTER ECG TERMINAL

    K Number: K802272 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    COMPUTER ECG TERMINAL
    K Number
    K802272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Compumed, Inc.
    Date Received
    September 17, 1980
    Decision Date
    September 26, 1980
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Compumed, Inc.

    K Number Device Name
    K984285 OSTEOGRAM BONE DENSITOMETER
    K955708 COMPUMED DICON CLIENT
    K863965 KENZ-ECG 102
    K854626 COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
    K771648 COMPUTER ECG TERMINAL