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510(k) DEN030001

NIOX ARTICLE NO: 02-1000 by Aerocrine AB — Product Code MXA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 30, 2003
Date Received
March 18, 2003
Clearance Type
Post-NSE
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 by Aerocrine AB

  • 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)
  • K072816 — NIOX MINO (March 3, 2008)

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)
  • K170983 — NIOX VERO (November 22, 2017)
  • 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)