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

Clearance details

Applicant

Sein Electronics Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

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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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 →