The following data is part of a premarket notification filed by Syn-optics with the FDA for Syn-optics #5200.
| Device ID | K820624 |
| 510k Number | K820624 |
| Device Name: | SYN-OPTICS #5200 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | SYN-OPTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-01 |