510(k) K843806
K843806 is an FDA 510(k) premarket notification submitted by Vistek Corp. for the device "VIS-1000 VIDEO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 1984. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160. Vistek Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1984
- Date Received
- September 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Surgical And Accessories
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type