The following data is part of a premarket notification filed by Truevision Systems, Incorporated with the FDA for Truevision 3d Visualization And Guidance System.
| Device ID | K101861 |
| 510k Number | K101861 |
| Device Name: | TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TRUEVISION SYSTEMS, INCORPORATED 114 EAST HALEY STREET, SUITE L Santa Barbara, CA 93101 |
| Contact | Burton Tripathi |
| Correspondent | Burton Tripathi TRUEVISION SYSTEMS, INCORPORATED 114 EAST HALEY STREET, SUITE L Santa Barbara, CA 93101 |
| Product Code | HKI |
| Subsequent Product Code | EPT |
| Subsequent Product Code | NFJ |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2010-12-22 |
| Summary: | summary |