4 ms·

FDA-cleared pulse oximeters must be accurate to ±4% SpO2. https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda

• wlesieutre 5y ago
  Notably, the Apple Watch S6 sensor does not have FDA approval. It's for "wellness." https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-blood-oxygen-fda-clearance https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-... > Blood oxygen monitors, or pulse oximeters, are considered Class II medical devices by the FDA. Generally, any company that wants to sell one in the United States has to submit documentation to the agency confirming that its product works just as well as other versions of the same product already on the market. There’s a workaround, though: if the company says that the product is just for fun, or for general “wellness,” they don’t have to go through that process. They can’t claim that it can diagnose or treat any medical conditions, but they can put it up for sale. You might still use that as a cue that you should get tested for sleep apnea, but the watch itself isn't considered a medical device for measuring blood oxygen.