FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312— 510(k) K012054

Substantially Equivalent

Sein Electronics Co., Ltd.

FDA 510(k) clearance K012054 for FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312, Substantially Equivalent on 2001-08-08. Applicant: Sein Electronics Co., Ltd..

Clearance details

Applicant: Sein Electronics Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-07-02
Decision date: 2001-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-City, Kyunggi-Do, KR

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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.