Company ยท US
Aerocrine AB
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 2015 | K150233 | NIOX VERO Airway Inflammation Monitor Aerocrine AB, SE | MXA |
| Nov 6, 2014 | K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR Aerocrine AB | MXA |
| Dec 27, 2012 | K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR Aerocrine AB, SE | MXA |
| Sep 2, 2010 | K101034 | NIOX MINO MODEL 09-1000 Aerocrine AB, SE | MXA |
| Mar 3, 2008 | K072816 | NIOX MINO Aerocrine AB | MXA |
| Apr 30, 2003 | DEN030001 | NIOX ARTICLE NO: 02-1000 Aerocrine AB | MXA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||