The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Pulse Oximetry (sao2) Monitor Capabil.
| Device ID | K901774 |
| 510k Number | K901774 |
| Device Name: | HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL |
| Classification | Oximeter |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | G Whitehead |
| Correspondent | G Whitehead MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-19 |
| Decision Date | 1990-05-22 |