The following data is part of a premarket notification filed by Aviche Shandong Medical Technology Co, Ltd. with the FDA for Automatic Digital Blood Pressure Monitor.
| Device ID | K210152 |
| 510k Number | K210152 |
| Device Name: | Automatic Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AVICHE Shandong Medical Technology Co, Ltd. Floor 26, Building A, A2-1 Jinan Pharm Valley Gangxingsan Road, High-tech District Jinan, CN |
| Contact | Zhike Song |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-09-23 |