Arm-Type Fully Automatic Digital Blood Pressure Monitor— 510(k) K161577

Substantially Equivalent

Sejoy Electronics & Instruments Co., Ltd.

FDA 510(k) clearance K161577 for Arm-Type Fully Automatic Digital Blood Pressure Monitor, Substantially Equivalent on 2017-02-08. Applicant: Sejoy Electronics & Instruments Co., Ltd..

Clearance details

Applicant: Sejoy Electronics & Instruments Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-06-07
Decision date: 2017-02-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hang Zhou, 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.