The following data is part of a premarket notification filed by Oktas with the FDA for Oktas Stereo Viewing System.
| Device ID | K944254 |
| 510k Number | K944254 |
| Device Name: | OKTAS STEREO VIEWING SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | OKTAS 134 FLANDERS RD. Westborough, MA 01581 |
| Contact | Ken Hori |
| Correspondent | Ken Hori OKTAS 134 FLANDERS RD. Westborough, MA 01581 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-11-30 |