Cleared Special

NOxBOXi Nitric Oxide Delivery System

K220898 · Linde Gas & Equipment, Inc. · Anesthesiology

Apr 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K220898 is an FDA 510(k) clearance for the NOxBOXi Nitric Oxide Delivery System, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by Linde Gas & Equipment, Inc. (Tonawanda, US). The FDA issued a Cleared decision on April 27, 2022, 30 days after receiving the submission on March 28, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number	K220898 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2022
Decision Date	April 27, 2022
Days to Decision	30 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF