NIOX MINO
FDA 510(k) clearance K072816 · decided 2008-03-03
Clearance details
- K-number
- K072816
- Device name
- NIOX MINO
- Applicant
- Aerocrine AB
- Decision
- Substantially Equivalent
- Date received
- 2007-10-02
- Decision date
- 2008-03-03
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- MXA
- Device class
- 2
- Regulation number
- 862.3080
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| NIOX VERO (K170983) | Circassia AB | 2017-11-22 |
| NIOX VERO Airway Inflammation Monitor (K150233) | Aerocrine AB | 2015-02-26 |
| NIOX VERO AIRWAY INFLAMMATION MONITOR (K133898) | Aerocrine AB | 2014-11-06 |
| NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (K123683) | Aerocrine AB | 2012-12-27 |
| NIOX MINO MODEL 09-1000 (K101034) | Aerocrine AB | 2010-09-02 |
| APIERON INSIGHT ENO SYSTEM (K083617) | Apieron, Inc. | 2009-01-27 |
Recalls involving this device
No recalls on record reference this clearance.