The following data is part of a premarket notification filed by Aerocrine Ab with the FDA for Niox Vero Airway Inflammation Monitor.
| Device ID | K150233 |
| 510k Number | K150233 |
| Device Name: | NIOX VERO Airway Inflammation Monitor |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | AEROCRINE AB RASUNDAVAGEN 18, 8TH FLOOR Solna, SE Se-169 67 |
| Contact | Kathleen Rickard |
| Correspondent | Kathleen Rickard AEROCRINE AB RASUNDAVAGEN 18, 8TH FLOOR Solna, SE Se-169 67 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-02-26 |
| Summary: | summary |