Cleared Traditional

NIOX VERO

K170983 · Circassia AB · Chemistry
Nov 2017
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K170983 is an FDA 510(k) clearance for the NIOX VERO, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Circassia AB (Uppsala, SE). The FDA issued a Cleared decision on November 22, 2017, 233 days after receiving the submission on April 3, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K170983 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2017
Decision Date November 22, 2017
Days to Decision 233 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MXA — System, Test, Breath Nitric Oxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3080