The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Fingertip Pulse Oximeter Md300cn310.
| Device ID | K161560 |
| 510k Number | K161560 |
| Device Name: | Fingertip Pulse Oximeter MD300CN310 |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Contact | Lei Chen |
| Correspondent | Lei Chen 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 | 2016-06-06 |
| Decision Date | 2016-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782564964 | K161560 | 000 |
| 00860298000119 | K161560 | 000 |
| 00860298000102 | K161560 | 000 |
| 00860298000010 | K161560 | 000 |
| 10810038630004 | K161560 | 000 |