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

    THERMOCHEM HT-2000

    K Number: K131583 · Decision Oct 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    THERMOCHEM HT-2000
    K Number
    K131583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermasolutions, Inc.
    Date Received
    May 31, 2013
    Decision Date
    October 3, 2013
    Product Code
    MLW
    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
    MLW Warmer, Peritoneal Dialysate

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