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

    PC-180 / PRINCE 180 EASY ECG MONITOR

    K Number: K073152 · Decision Jan 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    11
    Review Days
    63

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    Basic Information

    Device Name
    PC-180 / PRINCE 180 EASY ECG MONITOR
    K Number
    K073152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Creative Industry Co., Ltd.
    Date Received
    November 8, 2007
    Decision Date
    January 10, 2008
    Product Code
    DSH
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSH Recorder, Magnetic Tape, Medical

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