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510(k) Data Aggregation

    K Number
    K033642
    Device Name
    SMARTLANK WIRELESS, MODEL 001970
    Date Cleared
    2004-05-25

    (187 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MRL, A WELCH ALLYN COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartLink Wireless system's primary function is to transfer 12 lead and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for patient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient upon arrival. The SmartLink Wireless system can be used to: - Provide users of Welch Allyn PIC 50 products in the field the capability of transmitting patient vitals using wireless technology to a remote location. At the remote location the information will be used for diagnostic purposes by trained medical personnel. Patient's vitals may include 12 lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot. - Send automatic pager notification when a new patient record is received at the personal computer station. - Forward the patient data to any number of e-mail address at remote computers or personal digital assistants. The SmartLink Wireless system is not intended to be used as a primary alarm source. Patient information received by the SmartLink Wireless system should not be examined for the purpose of generating alarms.
    Device Description
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