The following data is part of a De Novo classification by Fresca Medical with the FDA for Curve Positive Airway Pressure System.
| DeNovo ID | DEN170089 |
| Device Name: | Curve Positive Airway Pressure System |
| Classification | Positive Airway Pressure System |
| Applicant | FRESCA Medical 1291 Puerta Del Sol, Suite 200 San Clemente, CA 92673 |
| Contact | Mary Lou Mooney |
| Product Code | QBY |
| CFR Regulation Number | 868.5273 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | Anesthesiology |
| Type | Direct |
| Date Received | 2017-12-14 |
| Decision Date | 2018-06-05 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |