510(k) K860173
K860173 is an FDA 510(k) premarket notification submitted by Vistek Corp. for the device "VIS-2000 VIDEO SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code FWG (Camera, Television, Endoscopic, With Audio), 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
- February 7, 1986
- Date Received
- January 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, With Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type