510(k) K934093
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1994
- Date Received
- August 23, 1993
- 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