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

    THERMAL ANGEL

    K Number: K984640 · Decision Jul 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    182

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    Basic Information

    Device Name
    THERMAL ANGEL
    K Number
    K984640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9205
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Estill Medical Technologies, Inc.
    Date Received
    December 31, 1998
    Decision Date
    July 1, 1999
    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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    Other Clearances by Estill Medical Technologies, Inc.

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