The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon Xl.
| Device ID | K911616 |
| 510k Number | K911616 |
| Device Name: | HORIZON XL |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Richard G Whitehead |
| Correspondent | Richard G Whitehead MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-07-10 |