Cleared Traditional

Inomax DSIR

K211153 · Mallinckrodt Manufacturing, LLC · Anesthesiology
Apr 2023
Decision
731d
Days
Class 2
Risk

About This 510(k) Submission

K211153 is an FDA 510(k) clearance for the Inomax DSIR, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by Mallinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on April 20, 2023, 731 days after receiving the submission on April 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number K211153 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2021
Decision Date April 20, 2023
Days to Decision 731 days
Submission Type Traditional
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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