The following data is part of a premarket notification filed by Witt Biomedical Corporation with the FDA for Witt Biomedical Vx-80.
| Device ID | K880258 |
| 510k Number | K880258 |
| Device Name: | WITT BIOMEDICAL VX-80 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | WITT BIOMEDICAL CORPORATION 238 HARBOUR DRIVE EAST Indian Harbour Bch, FL 32937 |
| Contact | Terence R Witt |
| Correspondent | Terence R Witt WITT BIOMEDICAL CORPORATION 238 HARBOUR DRIVE EAST Indian Harbour Bch, FL 32937 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-22 |
| Decision Date | 1988-06-16 |