510(k) K162817
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2017
- Date Received
- October 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Communication, Powered
- Device Class
- Class II
- Regulation Number
- 890.3710
- Review Panel
- PM
- Submission Type