The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Fraction Of Inspired Oxygen Mon. Cap..
| Device ID | K894918 |
| 510k Number | K894918 |
| Device Name: | HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Richard Whitehead |
| Correspondent | Richard Whitehead MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-10-31 |