The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Transcutaneous Gas Monitoring.
| Device ID | K860124 |
| 510k Number | K860124 |
| Device Name: | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald Widman |
| Correspondent | Ronald Widman 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 | 1986-01-14 |
| Decision Date | 1986-05-09 |