NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR— 510(k) K123683

Name: FDA 510(k) clearance K123683
Creator: U.S. Food and Drug Administration
Published: 2012-12-27

Substantially Equivalent

Aerocrine AB

FDA 510(k) clearance K123683 for NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR, Substantially Equivalent on 2012-12-27. Applicant: Aerocrine AB. Device class: 2.

Clearance details

Applicant: Aerocrine AB
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2012-11-30
Decision date: 2012-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

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