BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    TYPE 9210 ECG SYSTEM ATHENA

    K Number: K884117 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    46
    Review Days
    208

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    Basic Information

    Device Name
    TYPE 9210 ECG SYSTEM ATHENA
    K Number
    K884117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    September 30, 1988
    Decision Date
    April 26, 1989
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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