NIOX MINO— 510(k) K072816

Substantially Equivalent

Aerocrine AB

FDA 510(k) clearance K072816 for NIOX MINO, Substantially Equivalent on 2008-03-03. 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: 2007-10-02
Decision date: 2008-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXA

K251674 — Fenom Flo FeNO Monitoring System2025-11-26
K243926 — Vivatmo pro-S2025-09-11
K233775 — Vivatmo pro2024-02-22
K213611 — Fenom Pro2023-06-07
K203695 — NObreath®2021-12-17

More clearances from Aerocrine AB

K150233 — NIOX VERO Airway Inflammation Monitor2015-02-26
K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR2014-11-06
K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR2012-12-27
K101034 — NIOX MINO MODEL 09-10002010-09-02
DEN030001 — NIOX ARTICLE NO: 02-10002003-04-30

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