510(k) K101034
- Device
- NIOX MINO MODEL 09-1000
- Applicant
- AEROCRINE AB
- 510(k) number
- K101034
- Product code
- MXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-02
- Date received
- 2010-04-14
- Regulation
- 862.3080
- Classification name
- System, Test, Breath Nitric Oxide
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHANNA KARLING
- Address
- Sundbybergsvagen 9 P.O. Box 1024 Solna SE SE-17121 SE-17121
FDA Registration Numbers#
- 3012926714
- 3003630525
- 3014353045
- 9612890
- 3008662397
- 2183022
- 3003366417
- 3009642126
- 3004167884
- 3001082393
Source Documents#
Other 510(k) Records For Product Code MXA #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary