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..
Clearance details
- Applicant
- Sein Electronics Co., Ltd.
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
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.