The following data is part of a premarket notification filed by Vesta, Inc. with the FDA for Silicone Rugger Disposable Yoke-cpap.
| Device ID | K834078 |
| 510k Number | K834078 |
| Device Name: | SILICONE RUGGER DISPOSABLE YOKE-CPAP |
| Classification | Airway, Nasopharyngeal |
| Applicant | VESTA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1983-12-27 |