510(k) K162643
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2016
- Date Received
- September 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type