DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400— 510(k) K042014

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

2004-07-27

Decision date

2004-08-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Alpharetta, GA, US

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• K052108 — SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-1002005-12-07
• K042138 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-3112004-08-24
• K032927 — FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR2004-05-07
• K012054 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-3122001-08-08
• K003711 — AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P2000-12-15

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 →