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510(k) K170983

NIOX VERO by Circassia AB — Product Code MXA

K170983 is an FDA 510(k) premarket notification submitted by Circassia AB for the device "NIOX VERO". The FDA issued a decision of Substantially Equivalent on November 22, 2017. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2017
Date Received
April 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Breath Nitric Oxide
Device Class
Class II
Regulation Number
862.3080
Review Panel
CH
Submission Type

Other clearances for product code MXA

  • K251674 — Fenom Flo™ FeNO Monitoring System (November 26, 2025)
  • K243926 — Vivatmo pro-S (September 11, 2025)
  • K233775 — Vivatmo pro (February 22, 2024)
  • K213611 — Fenom Pro (June 7, 2023)
  • K203695 — NObreath® (December 17, 2021)
  • K182874 — Fenom Pro Nitric Oxide Test (February 13, 2019)
  • K150233 — NIOX VERO Airway Inflammation Monitor (February 26, 2015)
  • K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR (November 6, 2014)
  • K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (December 27, 2012)
  • K101034 — NIOX MINO MODEL 09-1000 (September 2, 2010)

FDA data resources