The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for Integrated Visualization System.
| Device ID | K925108 |
| 510k Number | K925108 |
| Device Name: | INTEGRATED VISUALIZATION SYSTEM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1993-01-29 |