BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION

    K Number: K141582 · Decision Jul 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
    K Number
    K141582
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn
    Date Received
    June 13, 2014
    Decision Date
    July 11, 2014
    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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