The Blood Oxygen Module Used In Combination With Ventilators Shall Be Clinically Evaluated Through Laboratory Human Study. If The Product Is Not Marketed In China, Whether The Racial Difference (difference In Skin Color Evaluation) Shall Be Considered In This Evaluation?


The ethnic differences should be considered and the data of Chinese or Asian Americans should be included.

Recommendations based on clinical evaluation of blood oxygen: The manufacturer is advised to consider the age of patients. Different ages should be included as widely as possible, covering at least 18 to 45 years old. The problem of skin melanin precipitation should be considered in this clinical study. Subjects with different degrees of melanin precipitation (or dark skin) should be included, involving at least two subjects with melanin precipitation or at least 15% of subjects with melanin precipitation (whichever is larger).