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

    Renew NCP-5 External Counterpulsation System

    K Number: K152115 · Decision Dec 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    141

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    Basic Information

    Device Name
    Renew NCP-5 External Counterpulsation System
    K Number
    K152115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stage 2 Innovations
    Date Received
    July 29, 2015
    Decision Date
    December 17, 2015
    Product Code
    DRN
    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
    DRN Device, Counter-Pulsating, External

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