Masimo W1 Medical Watch Gets FDA Clearance for OTC and Prescription Use
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Dow Jones
By Stephen Nakrosis
Masimo on Friday said the Masimo W1 medical watch received 510(k) clearance from the U.S. Food and Drug Administration for over-the-counter and prescription use
The Masimo W1 is "the first FDA-cleared watch to provide continuous real-time oxygen saturation and pulse rate for OTC and Rx use," the company said.
Data from the integrated Masimo MW-1 module is displayed in real-time on the Masimo W1 watch touchscreen, the company said.
Section 510(k) of the Food, Drug and Cosmetic Act requires manufacturers to give the FDA 90 days advance notice before they can market a medical device.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 17, 2023 16:58 ET (21:58 GMT)
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