The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 1000 Cardiac Monitor.
| Device ID | K850880 |
| 510k Number | K850880 |
| Device Name: | HORIZON 1000 CARDIAC MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald A Widman |
| Correspondent | Ronald A Widman 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 | 1985-03-04 |
| Decision Date | 1985-04-25 |