The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
| Device ID | K181503 |
| 510k Number | K181503 |
| Device Name: | Fingertip 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 | 2018-06-07 |
| Decision Date | 2018-10-11 |
| Summary: | summary |