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

    Hach CM130 Chlorine Monitoring System

    K Number: K162471 · Decision Mar 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    205

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    Basic Information

    Device Name
    Hach CM130 Chlorine Monitoring System
    K Number
    K162471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hach Company
    Date Received
    September 6, 2016
    Decision Date
    March 30, 2017
    Product Code
    PSX
    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
    PSX Chlorine Meter

    Other Clearances by Hach Company

    K Number Device Name
    K070419 OPACIDEN OPA REAGENT STRIPS
    K042322 STERICHEK BLOOD LEAK REAGENT STRIPS
    K040660 STERICHEK GLUTARALDEHYDE REAGENT STRIPS