Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device— 510(k) K161886
Substantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.
FDA 510(k) clearance K161886 for Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device, Substantially Equivalent on 2016-10-14. Applicant: Guangdong Transtek Medical Electronics Co., Ltd..
Clearance details
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd.
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Zhongshan, 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.