The following data is part of a premarket notification filed by Shenzhen Yuezhongxing Technology Co., Ltd. with the FDA for Wrist Blood Pressure Monitor, Model Name:w203, Wrist Blood Pressure Monitor, Model Name:w202, Wrist Blood Pressure Monitor, Model Name:w1681.
| Device ID | K211041 |
| 510k Number | K211041 |
| Device Name: | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Yuezhongxing Technology Co., Ltd. No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, CN 518015 |
| Contact | Yuchao Chen |
| Correspondent | Yuchao Chen Shenzhen Yuezhongxing Technology Co., Ltd. No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, CN 518015 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2021-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971209160038 | K211041 | 000 |
| 06971209160151 | K211041 | 000 |
| 06971209160168 | K211041 | 000 |
| 06971209160175 | K211041 | 000 |
| 06971209160182 | K211041 | 000 |
| 06971209162018 | K211041 | 000 |
| 06971209162032 | K211041 | 000 |
| 06971209160045 | K211041 | 000 |
| 06971209160052 | K211041 | 000 |
| 06971209160069 | K211041 | 000 |
| 06971209160014 | K211041 | 000 |
| 06971209160021 | K211041 | 000 |
| 06971209162025 | K211041 | 000 |