The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Nitrox 30 - Anesthetic Gas Proportioner.
| Device ID | K771479 |
| 510k Number | K771479 |
| Device Name: | NITROX 30 - ANESTHETIC GAS PROPORTIONER |
| Classification | Gas-machine, Anesthesia |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-04 |
| Decision Date | 1977-11-07 |