510(k) K934093
K934093 is an FDA 510(k) premarket notification submitted by Vidco, Inc. for the device "580CDR DISPLAY DRIVER". The FDA issued a decision of Substantially Equivalent on August 18, 1994. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Vidco, Inc. has at least 6 other 510(k) clearances on record.
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