The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Handheld Ecg Monitor, Model Md100.
| Device ID | K093872 |
| 510k Number | K093872 |
| Device Name: | HANDHELD ECG MONITOR, MODEL MD100 |
| Classification | Electrocardiograph |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN RD. SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Contact | Yajing Li |
| Correspondent | Yajing Li BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN RD. SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-17 |
| Decision Date | 2010-03-31 |
| Summary: | summary |