NIOX VERO— 510(k) K170983

Substantially Equivalent

Circassia AB

FDA 510(k) clearance K170983 for NIOX VERO, Substantially Equivalent on 2017-11-22. Applicant: Circassia AB. Device class: 2.

Clearance details

Applicant: Circassia AB
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2017-04-03
Decision date: 2017-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.