BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph

    K Number: K210560 · Decision Jun 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    570
    Applicant Total
    10
    Review Days
    125

    Basic Information

    Device Name
    Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
    K Number
    K210560
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    February 25, 2021
    Decision Date
    June 30, 2021
    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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