Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312— 510(k) K172896

Substantially Equivalent

Shenzhen Jiacom Technology CO ., Ltd.

FDA 510(k) clearance K172896 for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312, Substantially Equivalent on 2018-01-26. Applicant: Shenzhen Jiacom Technology CO ., Ltd..

Clearance details

Applicant: Shenzhen Jiacom Technology CO ., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2017-09-22
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.