The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Pulse Oximeter (md300m/md300k2).
| Device ID | K152563 |
| 510k Number | K152563 |
| Device Name: | Pulse Oximeter (MD300M/MD300K2) |
| 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 | 2015-09-09 |
| Decision Date | 2016-04-18 |
| Summary: | summary |