The following data is part of a premarket notification filed by Shenzhen Yolanda Technology Co., Ltd with the FDA for Upper Arm Blood Pressure Monitor.
| Device ID | K221212 |
| 510k Number | K221212 |
| Device Name: | Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Yolanda Technology Co., Ltd Room 201, Jinfulai Building, No.49-1, Dabao Road, Dalang Area, Xinan Street, Baoan Shenzhen, CN 518000 |
| Contact | Xuejun Wang |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting., Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-08-26 |