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

    SmartHDM-510 System

    K Number: K201765 · Decision Sep 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    SmartHDM-510 System
    K Number
    K201765
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesa Laboratories, Inc.
    Date Received
    June 29, 2020
    Decision Date
    September 2, 2020
    Product Code
    FIZ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIZ Meter, Conductivity, Non-Remote

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