The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon Central Station.
| Device ID | K892066 |
| 510k Number | K892066 |
| Device Name: | HORIZON CENTRAL STATION |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Richard G Whitehead |
| Correspondent | Richard G Whitehead 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 | 1989-03-30 |
| Decision Date | 1989-06-22 |