FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311— 510(k) K042138
Substantially EquivalentSein Electronics Co., Ltd.
FDA 510(k) clearance K042138 for FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311, Substantially Equivalent on 2004-08-24. Applicant: Sein Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sein Electronics Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
Recent devices under product code DXN
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- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Sein Electronics Co., Ltd.
view all- K052108 — SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
- K042014 — DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
- K032927 — FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
- K012054 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
- K003711 — AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
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, through . 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.