510(k) K162089
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2017
- Date Received
- July 28, 2016
- Clearance Type
- Traditional
- 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