Cleared Traditional

NOxBOXi Nitric Oxide Delivery System

K233251 · Linde Gas & Equipment, Inc. · Anesthesiology

May 2024

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K233251 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. (Livingston, US). The FDA issued a Cleared decision on May 23, 2024, 238 days after receiving the submission on September 28, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number	K233251 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	May 23, 2024
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF