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

    THERMOCHEM-HT SYSTEM

    K Number: K993330 · Decision Dec 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    THERMOCHEM-HT SYSTEM
    K Number
    K993330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemocleanse, Inc.
    Date Received
    October 4, 1999
    Decision Date
    December 30, 1999
    Product Code
    MLW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    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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