The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Blood Pressure Monitor, Model Md200a.
| Device ID | K093013 |
| 510k Number | K093013 |
| Device Name: | BLOOD PRESSURE MONITOR, MODEL MD200A |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 20030 |
| Contact | Lee Fu |
| Correspondent | Lee Fu BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 20030 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-01-08 |
| Summary: | summary |