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 | K151206 |
| 510k Number | K151206 |
| 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 | 2015-05-06 |
| Decision Date | 2015-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10875011000038 | K151206 | 000 |