Medwaves Primo granted FDA 510(k) clearance
Medwave Inc. has received authorization from the U.S. Food and Drug Administration (FDA) to sell and market its Primo spot blood pressure monitoring product within the United States healthcare markets. Primo is a handheld spot blood pressure monitoring device, which is placed on the wrist, with accuracy comparable to an invasive arterial catheter. When on the wrist, the user presses a start key, and within approximately 12 seconds, blood pressure and pulse rate values are displayed. Primo requires no calibration or routine maintenance making it easy to use and extremely cost effective.
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