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

    SureTouch Mobile Pressure Mapping System

    K Number: K181672 · Decision Jun 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    368

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    Basic Information

    Device Name
    SureTouch Mobile Pressure Mapping System
    K Number
    K181672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2990
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sure, Inc.
    Date Received
    June 25, 2018
    Decision Date
    June 28, 2019
    Product Code
    NKA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NKA System, Documentation, Breast Lesion

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