The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000/s 266-xxx-xxx.
| Device ID | K880595 |
| 510k Number | K880595 |
| Device Name: | HORIZON 2000/S 266-XXX-XXX |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-05-06 |