The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Md2000b Vital Sign Monitor, Model Md2000b.
| Device ID | K100740 |
| 510k Number | K100740 |
| Device Name: | MD2000B VITAL SIGN MONITOR, MODEL MD2000B |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE, 999 Shanghai, Shanghai, CN 20020 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE, 999 Shanghai, Shanghai, CN 20020 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-16 |
| Decision Date | 2010-07-09 |
| Summary: | summary |