The following data is part of a premarket notification filed by Pulmonox Medical, Inc. with the FDA for Vianox Delivery System, Model Ii.
| Device ID | K033779 |
| 510k Number | K033779 |
| Device Name: | VIANOX DELIVERY SYSTEM, MODEL II |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | PULMONOX MEDICAL, INC. 10835-120 ST. SUITE 200 Edmonton, Ab, CA T5h 3p9 |
| Contact | Paula Tomat |
| Correspondent | Paula Tomat PULMONOX MEDICAL, INC. 10835-120 ST. SUITE 200 Edmonton, Ab, CA T5h 3p9 |
| Product Code | MRN |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2004-01-26 |
| Summary: | summary |