The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for 200 Series Gastro-intestinal Video System.
| Device ID | K944759 |
| 510k Number | K944759 |
| Device Name: | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJINON, INC. 10 HIGH POINT DR. Wayne, NJ 07470 |
| Contact | H J Evans |
| Correspondent | H J Evans FUJINON, INC. 10 HIGH POINT DR. Wayne, NJ 07470 |
| Product Code | FET |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| Subsequent Product Code | FDT |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-04-11 |