510(k) K151366
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2015
- Date Received
- May 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type