The following data is part of a premarket notification filed by Vision Systems Group, A Division Of Viking Systems with the FDA for Endoscopy Video Camera System.
| Device ID | K081585 |
| 510k Number | K081585 |
| Device Name: | ENDOSCOPY VIDEO CAMERA SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 10 GREENLAWN AVE South Grafton, MA 01560 |
| Contact | Christine E Nichols |
| Correspondent | Christine E Nichols VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 10 GREENLAWN AVE South Grafton, MA 01560 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-05 |
| Decision Date | 2008-06-20 |
| Summary: | summary |