FDA Product Code
FDA Product Code MXA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3080
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251674 | Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation | 2025-11-26 | Traditional | PDF ↗ |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | 2025-09-11 | Traditional | PDF ↗ |
| K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | 2024-02-22 | Traditional | PDF ↗ |
| K213611 | Fenom Pro | Caire Diagnostics, Inc. | 2023-06-07 | Traditional | PDF ↗ |
| K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019-02-13 | Traditional | PDF ↗ |
| K170983 | NIOX VERO | Circassia AB | 2017-11-22 | Traditional | PDF ↗ |
| K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015-02-26 | Special | PDF ↗ |
| K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | 2014-11-06 | Traditional | PDF ↗ |
| K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | 2012-12-27 | Special | PDF ↗ |
| K101034 | NIOX MINO MODEL 09-1000 | Aerocrine AB | 2010-09-02 | Special | PDF ↗ |
| K083617 | APIERON INSIGHT ENO SYSTEM | Apieron, Inc. | 2009-01-27 | Special | PDF ↗ |
| K073265 | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Apieron, Inc. | 2008-03-14 | Traditional | PDF ↗ |
| K072816 | NIOX MINO | Aerocrine AB | 2008-03-03 | Traditional | PDF ↗ |
| DEN030001 | NIOX ARTICLE NO: 02-1000 | Aerocrine AB | 2003-04-30 | Post-NSE | — |
Product code MXA · Class II · Clinical Toxicology. Data: openFDA.