The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2110/horizon 2210 264-xxx-xxx/261-xxx-xxx.
| Device ID | K893133 |
| 510k Number | K893133 |
| Device Name: | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| 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 | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-07-14 |