The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Arm-type Fully Automatic Digital Blood Pressure Monitor.
| Device ID | K152687 |
| 510k Number | K152687 |
| Device Name: | Arm-Type Fully Automatic Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, CN 310030 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-18 |
| Decision Date | 2015-10-16 |
| Summary: | summary |