BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INTRATEMP SOLUTION WARMER

    K Number: K083417 · Decision Jan 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    INTRATEMP SOLUTION WARMER
    K Number
    K083417
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    C Change Surgical, LLC
    Date Received
    November 18, 2008
    Decision Date
    January 13, 2009
    Product Code
    LHC
    Advisory Committee
    Physical Medicine
    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
    LHC Warmer, Irrigation Solution

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    Other Clearances by C Change Surgical, LLC

    K Number Device Name
    K051819 C CHANGE SOLUTION WARMER