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

    IntraTemp Solution Warmer

    K Number: K150190 · Decision Feb 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    IntraTemp Solution Warmer
    K Number
    K150190
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ecolab, Inc.
    Date Received
    January 27, 2015
    Decision Date
    February 26, 2015
    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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