The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Arrhythmia Monitoring Option.
| Device ID | K881273 |
| 510k Number | K881273 |
| Device Name: | HORIZON 2000 ARRHYTHMIA MONITORING OPTION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Thomas Connelly |
| Correspondent | Thomas 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 | 1988-03-25 |
| Decision Date | 1988-07-12 |