The following data is part of a premarket notification filed by Corpak Co. with the FDA for Opti- System.
| Device ID | K810559 |
| 510k Number | K810559 |
| Device Name: | OPTI- SYSTEM |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | CORPAK CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-03 |
| Decision Date | 1981-03-17 |