![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Masimo Gains FDA Clearance for O3 Regional Oximetry
Masimo Gains FDA Clearance for O3 Regional Oximetry
![](https://www.fdanews.com/ext/resources/test/Device_Images5/Brain_SideView.gif?t=1474538952&width=430)
The FDA has granted 510(k) clearance to Masimo’s O3 regional oximetry, the Irvine, Calif.-based company announced Monday.
The device is designed to continuously monitor cerebral oxygen saturation with near-infrared spectroscopy. — Anisa Jibrell
Upcoming Events
-
21Oct