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

    DRAEGER JAUNDICE METER JM-105

    K Number: K133175 · Decision Nov 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    48
    Review Days
    392

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    Basic Information

    Device Name
    DRAEGER JAUNDICE METER JM-105
    K Number
    K133175
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1113
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Systems, Inc.
    Date Received
    October 17, 2013
    Decision Date
    November 13, 2014
    Product Code
    MQM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQM Bilirubin (Total And Unbound) In The Neonate Test System

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