The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Md2000a Vital Sign Monitor, Model Md2000a.
| Device ID | K083466 |
| 510k Number | K083466 |
| Device Name: | MD2000A VITAL SIGN MONITOR, MODEL MD2000A |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D, ZHONGXIN ZHONGSHAN NO19, LN999, ZHONG SHAN NAN ER Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D, ZHONGXIN ZHONGSHAN NO19, LN999, ZHONG SHAN NAN ER Shanghai, CN 200030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817698020704 | K083466 | 000 |