The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Fully Automatic Electronic Blood Pressure Monitor.
| Device ID | K183535 |
| 510k Number | K183535 |
| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-06-04 |