The following data is part of a premarket notification filed by Optik with the FDA for Coast Video Endoscopic Imaging System.
| Device ID | K926166 |
| 510k Number | K926166 |
| Device Name: | COAST VIDEO ENDOSCOPIC IMAGING SYSTEM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
| Contact | John M Ahern |
| Correspondent | John M Ahern OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1993-06-01 |