The following data is part of a premarket notification filed by Apnicure, Inc. with the FDA for Winx Sleep Therapy System.
| Device ID | K130538 |
| 510k Number | K130538 |
| Device Name: | WINX SLEEP THERAPY SYSTEM |
| Classification | Intraoral Pressure Gradient Device |
| Applicant | APNICURE, INC. 900 CHESAPEAKE DR Redwood City, CA 94063 |
| Contact | Chris Daniel |
| Correspondent | Chris Daniel APNICURE, INC. 900 CHESAPEAKE DR Redwood City, CA 94063 |
| Product Code | OZR |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-01 |
| Decision Date | 2013-05-22 |
| Summary: | summary |