510(k) K161886
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device by
Guangdong Transtek Medical Electronics Co., Ltd.
— Product Code DXN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2016
- Date Received
- July 11, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type