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)— 510(k) K150545

Substantially Equivalent

Sejoy Electronics & Instruments Co., Ltd.

FDA 510(k) clearance K150545 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), Substantially Equivalent on 2015-04-02. Applicant: Sejoy Electronics & Instruments Co., Ltd..

Clearance details

Applicant: Sejoy Electronics & Instruments Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-03-03
Decision date: 2015-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.