The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 9000.
| Device ID | K875167 |
| 510k Number | K875167 |
| Device Name: | HORIZON 9000 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Lewis, Phd |
| Correspondent | Lewis, Phd MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-16 |
| Decision Date | 1988-05-31 |