The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 9000/his Option Amplifier.
| Device ID | K914381 |
| 510k Number | K914381 |
| Device Name: | HORIZON 9000/HIS OPTION AMPLIFIER |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald A Brandt |
| Correspondent | Ronald A Brandt MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-03 |
| Decision Date | 1992-01-28 |