BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE

    K Number: K971038 · Decision Sep 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    1
    Review Days
    188

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    Basic Information

    Device Name
    KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE
    K Number
    K971038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kontron Instruments , Ltd.
    Date Received
    March 20, 1997
    Decision Date
    September 24, 1997
    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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