The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Video Camera System.
| Device ID | K863598 |
| 510k Number | K863598 |
| Device Name: | VIDEO CAMERA SYSTEM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Dieck, Phd |
| Correspondent | Dieck, Phd AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1986-10-02 |