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

    WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0

    K Number: K101674 · Decision Jul 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
    K Number
    K101674
    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
    June 15, 2010
    Decision Date
    July 21, 2010
    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

    K Number Device Name
    K191989 WVSM (Wireless Vital Signs Monitor) RWC + miniCap
    K173203 Athena GTX Device Management Suite (ADMS) Software
    K160582 WiCap
    K153459 TACVAC
    K130957 WVSM (WIRLESS VITAL SIGNS MONITOR)
    K113165 MINI-MEDIC