The following data is part of a premarket notification filed by Huizhou Xiaoou Technology Co., Ltd. with the FDA for Pulse Oximeter (model Number-so611), Pulse Oximeter (model Number- S0711), Pulse Oximeter (s0811), Pulse Oximeter (s0911).
| Device ID | K212665 |
| 510k Number | K212665 |
| Device Name: | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) |
| Classification | Oximeter |
| Applicant | Huizhou Xiaoou Technology Co., Ltd. 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou, CN 516000 |
| Contact | Xia Wang |
| Correspondent | Xia Wang Huizhou Xiaoou Technology Co., Ltd. 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou, CN 516000 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-06-22 |