The following data is part of a premarket notification filed by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. with the FDA for Automatic Arm Electronic Blood Pressure Monitor.
| Device ID | K210435 |
| 510k Number | K210435 |
| Device Name: | Automatic Arm Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North Side Of Floor 3, BLD 9 BaiWangxin High-Tech Industrial Park, Songbai Road Shenzhen, CN 518055 |
| Contact | Aaron Lin |
| Correspondent | Arthur Goddard FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights, OH 44124 -4445 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-12 |
| Decision Date | 2021-05-12 |