Ann: Annual Report to Shareholders, page-42

Well, I suppose its the CFDA that most are concerned about. Found the clearance from FDA and this part looks interesting to me.

https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170181.pdf

CLINICAL DATA
Clinical Validation Prizma Finger Oximeter
The SpO2 function was validated in a clinical study at the Bickler Ye Hypoxia Research Laboratory, Shenzhen Medical University, China (report # BYL20160415).

So this means FDA actually take in consideration of clinical data from China too right? If that is the case...