UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES— 510(k) K092514
Substantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,
FDA 510(k) clearance K092514 for UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES, Substantially Equivalent on 2009-12-04. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,.
Clearance details
- Applicant
- Hangzhou Hua'An Medical & Health Instruments Co.,
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuchang, Hangzhou, Zhejiang, CN
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.