FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR— 510(k) K032927

Substantially Equivalent

Sein Electronics Co., Ltd.

FDA 510(k) clearance K032927 for FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR, Substantially Equivalent on 2004-05-07. Applicant: Sein Electronics Co., Ltd..

Clearance details

Applicant: Sein Electronics Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2003-09-22
Decision date: 2004-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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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.