The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Transcutaneous Gas #26x-opt-275.
| Device ID | K885079 |
| 510k Number | K885079 |
| Device Name: | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 |
| Classification | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald A Widman |
| Correspondent | Ronald A Widman MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | LPP |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-08 |
| Decision Date | 1989-02-17 |