The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Endoscopic Videosystem.
| Device ID | K822959 |
| 510k Number | K822959 |
| Device Name: | ENDOSCOPIC VIDEOSYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | EDER INSTRUMENT CO, INC. 735 NORTH WATER ST. SUITE 1102 Milwaukee, Wi 53202, 53202 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-05 |
| Decision Date | 1982-10-22 |