The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Eeg Monitoring Option.
| Device ID | K910945 |
| 510k Number | K910945 |
| Device Name: | HORIZON 2000 EEG MONITORING OPTION |
| Classification | Full-montage Standard Electroencephalograph |
| 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-08-15 |