The following data is part of a premarket notification filed by Marks & Murase with the FDA for Series 400 Gastroenterology System.
| Device ID | K944620 |
| 510k Number | K944620 |
| Device Name: | SERIES 400 GASTROENTEROLOGY SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Gary A Adler |
| Correspondent | Gary A Adler MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | FET |
| 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 | 1994-09-20 |
| Decision Date | 1995-04-27 |