The following data is part of a premarket notification filed by Witt Biomedical Corporation with the FDA for Witt Biomedical Image Iii.
| Device ID | K945582 |
| 510k Number | K945582 |
| Device Name: | WITT BIOMEDICAL IMAGE III |
| Classification | System, Image Processing, Radiological |
| Applicant | WITT BIOMEDICAL CORPORATION 295 NORTH DR., SUITE H Melbourne, FL 32934 |
| Contact | Erencene R Witt |
| Correspondent | Erencene R Witt WITT BIOMEDICAL CORPORATION 295 NORTH DR., SUITE H Melbourne, FL 32934 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-06-19 |