The following data is part of a premarket notification filed by Apnicure, Inc. with the FDA for Attune Sleep Apnea System.
| Device ID | K111549 |
| 510k Number | K111549 |
| Device Name: | ATTUNE SLEEP APNEA 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-03 |
| Decision Date | 2012-03-30 |
| Summary: | summary |