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

    MINI-MEDIC

    K Number: K113165 · Decision Feb 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    7
    Review Days
    99

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    Basic Information

    Device Name
    MINI-MEDIC
    K Number
    K113165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Athena Gtx
    Date Received
    October 26, 2011
    Decision Date
    February 2, 2012
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Athena Gtx

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    K153459 TACVAC
    K130957 WVSM (WIRLESS VITAL SIGNS MONITOR)
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