Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
FDA 510(k) clearance K161886 · decided 2016-10-14
Clearance details
- K-number
- K161886
- Device name
- Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-11
- Decision date
- 2016-10-14
- Days to decision
- 95 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Zhongshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.