The following data is part of a premarket notification filed by Ventus Medical, Inc. with the FDA for Provent Nasal Dilator, Model Br2.
| Device ID | K071560 |
| 510k Number | K071560 |
| Device Name: | PROVENT NASAL DILATOR, MODEL BR2 |
| Classification | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Applicant | VENTUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus VENTUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Product Code | OHP |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2008-02-08 |
| Summary: | summary |