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Masimo W1 Medical Watch receives FDA 510k clearance

Masimo announced the Masimo W1 medical watch has received FDA 510(k) clearance for over-the-counter and prescription use. Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation and pulse rate for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device for use by adults in hospitals, clinics, long-term care facilities, and in the home. Developed to be comfortable and lifestyle-friendly, the Masimo W1 medical watch empowers users with untethered continuous pulse oximetry as they move about their lives – no matter where they are.

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