https://wccftech.com/apple-watch-series-6-blood-oxygen-monitor-no-fda-approval/

When the electrocardiogram or ECG feature debuted on the Apple Watch Series 4, the company needed FDA approval to allow it to be functional on the wearable. With the Apple Watch Series 6 a device that sports both ECG and an oximeter, the trillion-dollar tech giant didn’t need clearance, at least for the newest feature found on the smartwatch. If you’re wondering why this is the case, a comprehensive report delivers insight which will be interesting to you.

Any company that is developing and selling Class II medical devices such as a pulse oximeters will need to obtain approval from the FDA. Additionally, any company that wants to sell one will need to make sure that the documentation describing the pulse oximeter mentions that the product works just as well as the existing versions sold in the market. Apple didn’t need to go through this arduous process. Why might you ask?