The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
| Device ID | K141128 |
| 510k Number | K141128 |
| Device Name: | FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Contact | Lei Chen |
| Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY 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 | 2014-05-01 |
| Decision Date | 2014-08-13 |
| Summary: | summary |