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

    MODIFICATION TO THERMAL ANGEL

    K Number: K012031 · Decision Jul 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    MODIFICATION TO THERMAL ANGEL
    K Number
    K012031
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.9205
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ESTILL MEDICAL TECHNOLOGIES, INC.
    Date Received
    June 28, 2001
    Decision Date
    July 26, 2001
    Product Code
    BSB
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSB Warmer, Blood, Non-Electromagnetic Radiation

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