The following data is part of a premarket notification filed by Ventus Medical, Inc. with the FDA for Provent Nasal Cannula.
| Device ID | K080983 |
| 510k Number | K080983 |
| Device Name: | PROVENT NASAL CANNULA |
| Classification | Ventilatory Effort Recorder |
| Applicant | VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 340 Belmont, CA 94002 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 340 Belmont, CA 94002 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-08-07 |
| Summary: | summary |