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

    WiCap

    K Number: K160582 · Decision Sep 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    185

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    Basic Information

    Device Name
    WiCap
    K Number
    K160582
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Athena Gtx
    Date Received
    March 1, 2016
    Decision Date
    September 2, 2016
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Athena Gtx

    K Number Device Name
    K191989 WVSM (Wireless Vital Signs Monitor) RWC + miniCap
    K173203 Athena GTX Device Management Suite (ADMS) Software
    K153459 TACVAC
    K130957 WVSM (WIRLESS VITAL SIGNS MONITOR)
    K113165 MINI-MEDIC
    K101674 WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0