FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
NIOX VERO Airway Inflammation Monitor
K Number: K150233
·
Decision Feb 26, 2015
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
12
Applicant Total
6
Review Days
24
Basic Information
- Device Name
- NIOX VERO Airway Inflammation Monitor
- K Number
- K150233
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3080
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AEROCRINE AB
- Date Received
- February 2, 2015
- Decision Date
- February 26, 2015
- Product Code
- MXA
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | FDA class 2 | Clinical Toxicology |
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Other Clearances by AEROCRINE AB
| K Number | Device Name | ||
|---|---|---|---|
| K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | Nov 6, 2014 | Substantially Equivalent |
| K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Dec 27, 2012 | Substantially Equivalent |
| K101034 | NIOX MINO MODEL 09-1000 | Sep 2, 2010 | Substantially Equivalent |
| K072816 | NIOX MINO | Mar 3, 2008 | Substantially Equivalent |
| DEN030001 | NIOX ARTICLE NO: 02-1000 | Apr 30, 2003 | Unknown |