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 | K160565 |
| 510k Number | K160565 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-08-10 |
| Summary: | summary |