The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Arrhythmia Monitor Option - (alarms).
| Device ID | K885204 |
| 510k Number | K885204 |
| Device Name: | HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Thomas W Connelly |
| Correspondent | Thomas W Connelly MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-19 |
| Decision Date | 1989-04-19 |