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

    Getinge Series Warming Cabinet

    K Number: K153713 · Decision Jun 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    166

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    Basic Information

    Device Name
    Getinge Series Warming Cabinet
    K Number
    K153713
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge Sourcing, LLC
    Date Received
    December 24, 2015
    Decision Date
    June 7, 2016
    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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    K103504 GETINGE 400HC/500HC SERIES STEAM STERILIZER
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