The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Wrist-type Fully Automatic Digital Blood Pressure Monitor.
| Device ID | K121355 |
| 510k Number | K121355 |
| Device Name: | WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, Zhejiang, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, Zhejiang, CN 310030 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2012-07-18 |
| Summary: | summary |