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

    CERNER FETALINK (VERSION 1.0)

    K Number: K091251 · Decision Aug 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    7
    Review Days
    118

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    Basic Information

    Device Name
    CERNER FETALINK (VERSION 1.0)
    K Number
    K091251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cerner Corp.
    Date Received
    April 29, 2009
    Decision Date
    August 25, 2009
    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
    K121758 CERNER FETALINK+(VERSION1.0)
    K093134 CERNER CAREAWARE IBUS
    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