The following data is part of a premarket notification filed by Kgt Inc. with the FDA for Bf-navi.
| Device ID | K093810 |
| 510k Number | K093810 |
| Device Name: | BF-NAVI |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | KGT INC. 1705 S. CAPITAL OF TEXAS HWY., SUITE 500 Austin, TX 78746 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins KGT INC. 1705 S. CAPITAL OF TEXAS HWY., SUITE 500 Austin, TX 78746 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-06-18 |
| Summary: | summary |