The following data is part of a premarket notification filed by Ventus Medical, Inc. with the FDA for Provent Professional Sleep Apnea Therapy.
| Device ID | K090398 |
| 510k Number | K090398 |
| Device Name: | PROVENT PROFESSIONAL SLEEP APNEA THERAPY |
| Classification | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Applicant | VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 425 Belmont, CA 94002 |
| Contact | Mary Rose |
| Correspondent | Mary Rose VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 425 Belmont, CA 94002 |
| Product Code | OHP |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-04-03 |
| Summary: | summary |