510(k) K163649
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2017
- Date Received
- December 23, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Blood-Pressure
- Device Class
- Class II
- Regulation Number
- 870.1100
- Review Panel
- CV
- Submission Type