Cleared Special

NOxBOXi Nitric Oxide Delivery System

K231823 · Linde Gas & Equipment, Inc. · Anesthesiology

Aug 2023

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K231823 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 August 11, 2023, 51 days after receiving the submission on June 21, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number	K231823 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2023
Decision Date	August 11, 2023
Days to Decision	51 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF