BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    CER-S

    K Number: K193177 · Decision Aug 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    282

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    Basic Information

    Device Name
    CER-S
    K Number
    K193177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiocalm
    Date Received
    November 18, 2019
    Decision Date
    August 26, 2020
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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