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

    ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

    K Number: K202461 · Decision Aug 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    715

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    Basic Information

    Device Name
    ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
    K Number
    K202461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smisson-Cartledge Biomedical, LLC
    Date Received
    August 27, 2020
    Decision Date
    August 12, 2022
    Product Code
    LGZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGZ Warmer, Thermal, Infusion Fluid

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    Other Clearances by Smisson-Cartledge Biomedical, LLC

    K Number Device Name
    K052055 SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200