Product code MXA
- Device name
- System, Test, Breath Nitric Oxide
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3080
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | 2025-11-26 |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | 2025-09-11 |
| K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | 2024-02-22 |
| K213611 | Fenom Pro | Caire Diagnostics, Inc. | 2023-06-07 |
| K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021-12-17 |
| K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019-02-13 |
| K170983 | NIOX VERO | Circassia AB | 2017-11-22 |
| K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015-02-26 |
| K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | 2014-11-06 |
| K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | 2012-12-27 |
| K101034 | NIOX MINO MODEL 09-1000 | Aerocrine AB | 2010-09-02 |
| K083617 | APIERON INSIGHT ENO SYSTEM | Apieron, Inc. | 2009-01-27 |
| K073265 | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Apieron, Inc. | 2008-03-14 |
| K072816 | NIOX MINO | Aerocrine AB | 2008-03-03 |
| DEN030001 | NIOX ARTICLE NO: 02-1000 | Aerocrine AB | 2003-04-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060246860191 | NObreath® | BEDFONT SCIENTIFIC LIMITED | 2026-03-09 |
| 04059233002820 | Spare part: Vivatmo pro base station US | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233002813 | Spare part: Vivatmo pro handheld US | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233000048 | Vivatmo pro Oxycap | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233000307 | Vivatmo pro Level 0 | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233001274 | Vivatmo pro | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233000130 | Spare part: Vivatmo pro handheld US | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 04059233000123 | Spare part: Vivatmo pro base station US | Bosch Healthcare Solutions GmbH | 2024-07-08 |
| 00860008017932 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 00860008017956 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 00860008017949 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 00860008017925 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 00860008017918 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 00860008017901 | CAIRE Diagnostics | Caire Diagnostics Inc. | 2022-01-31 |
| 05060246860320 | FeNOBreath | BEDFONT SCIENTIFIC LIMITED | 2022-01-06 |
| 05060246860177 | NOBreath | BEDFONT SCIENTIFIC LIMITED | 2022-01-06 |
| 07350047030663 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030670 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030687 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030694 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030700 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030717 | NIOX | Circassia AB | 2021-10-28 |
| 07350047030168 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030113 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030106 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030076 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030069 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030052 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030458 | NIOX | Circassia AB | 2016-09-21 |
| 07350047030465 | NIOX | Circassia AB | 2016-09-21 |