NIOX VERO AIRWAY INFLAMMATION MONITOR— 510(k) K133898

Name: FDA 510(k) clearance K133898
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Substantially Equivalent

Aerocrine AB

FDA 510(k) clearance K133898 for NIOX VERO AIRWAY INFLAMMATION MONITOR, Substantially Equivalent on 2014-11-06. 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: 2013-12-20
Decision date: 2014-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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