The following data is part of a premarket notification filed by Aerocrine Ab with the FDA for Niox Vero Airway Inflammation Monitor.
| Device ID | K133898 |
| 510k Number | K133898 |
| Device Name: | NIOX VERO AIRWAY INFLAMMATION MONITOR |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | AEROCRINE AB 5151 MCCRIMMON PARKWAY Morrisville, NC 27560 |
| Contact | Susanne Parks |
| Correspondent | Susanne Parks AEROCRINE AB 5151 MCCRIMMON PARKWAY Morrisville, NC 27560 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350047030496 | K133898 | 000 |
| 07350047030670 | K133898 | 000 |
| 07350047030687 | K133898 | 000 |
| 07350047030694 | K133898 | 000 |
| 07350047030700 | K133898 | 000 |
| 07350047030717 | K133898 | 000 |
| 07350047030175 | K133898 | 000 |
| 07350047030267 | K133898 | 000 |
| 07350047030274 | K133898 | 000 |
| 07350047030281 | K133898 | 000 |
| 07350047030298 | K133898 | 000 |
| 07350047030366 | K133898 | 000 |
| 07350047030380 | K133898 | 000 |
| 07350047030472 | K133898 | 000 |
| 07350047030663 | K133898 | 000 |