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 (bp-1305, Bp-1307, Bp-1326, Bp-1318, Bp-1319, Bp-1211, Bp-1312, Bsp-11, Bsp-12, Bsp-13).
| Device ID | K150545 |
| 510k Number | K150545 |
| Device Name: | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. BLDG 2, NO. 202, ZHENZHONG RD WEST LAKE ECONOMY & TECH ZONE Hangzhou, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. BLDG 2, NO. 202, ZHENZHONG RD WEST LAKE ECONOMY & TECH 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 | 2015-03-03 |
| Decision Date | 2015-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488570933 | K150545 | 000 |
| 05060488570926 | K150545 | 000 |