The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K211400 |
| 510k Number | K211400 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing, CN 100041 |
| Contact | Haiying Zhao |
| Correspondent | Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing, CN 100041 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2022-02-11 |