BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CERNER FETALINK+(VERSION1.0)

    K Number: K121758 · Decision Oct 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    CERNER FETALINK+(VERSION1.0)
    K Number
    K121758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cerner Corp.
    Date Received
    June 15, 2012
    Decision Date
    October 9, 2012
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    Other Clearances by Cerner Corp.

    K Number Device Name
    K093134 CERNER CAREAWARE IBUS
    K091251 CERNER FETALINK (VERSION 1.0)
    K091032 CERNER PROVISION WORKSTATION (VERSION 2.5)
    K070394 CERNER PROVISION WORKSTATION
    K000770 PROVIEW MEDICAL IMAGE DISPLAY MODULE
    K955000 REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE