The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 1100 Cardiac Monitor.
| Device ID | K864843 |
| 510k Number | K864843 |
| Device Name: | HORIZON 1100 CARDIAC MONITOR |
| Classification | Electrocardiograph |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Spencer K Wende |
| Correspondent | Spencer K Wende MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-10 |
| Decision Date | 1987-03-16 |