Cleared Special

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

K193481 · International Biomedical · Anesthesiology
Mar 2020
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K193481 is an FDA 510(k) clearance for the AeroNOx 2.0 Nitric Oxide Titration & Monitoring System, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on March 10, 2020, 84 days after receiving the submission on December 17, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number K193481 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date March 10, 2020
Days to Decision 84 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MRN — Apparatus, Nitric Oxide Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5165

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