The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Vital Signs Monitor, Model: Md500b.
| Device ID | K082787 |
| 510k Number | K082787 |
| Device Name: | VITAL SIGNS MONITOR, MODEL: MD500B |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. #8D,ZHONGXIN ZHONGSHAN MANSION NO.19,LANE 999,ZHONG SHAN NAN Shanghai, Shanghai, CN 20020 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. #8D,ZHONGXIN ZHONGSHAN MANSION NO.19,LANE 999,ZHONG SHAN NAN Shanghai, Shanghai, CN 20020 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2009-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816703026991 | K082787 | 000 |