Regulatory Open Forum

  • 1.  Multifunction medical device which is OTC and Rx

    Posted 24-Apr-2014 03:06
    Does anyone know of a device with several medical functions (by way of example only: ECG, Heart Rate, Blood Glucose, Pulse Oximetry), where some of the functions are OTC and some are prescription, and the FDA has cleared the device via 510k as a multifunction OTC and Rx device? I am trying to understand the concept or principle of a combined multifunction OTC and Rx device - the actual medical functions are less important. 

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    Asher Kassel
    Lifewatch Technologies Ltd.
    Rehovot
    Israel
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