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

    NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE

    K Number: K142173 · Decision Dec 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    145

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    Basic Information

    Device Name
    NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
    K Number
    K142173
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ecolab, Inc.
    Date Received
    August 7, 2014
    Decision Date
    December 30, 2014
    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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