Cleared Special

INOmax DSIR Plus

K200389 · Mallinckrodt Manufacturing, LLC · Anesthesiology
Jun 2020
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K200389 is an FDA 510(k) clearance for the INOmax DSIR Plus, 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 June 17, 2020, 120 days after receiving the submission on February 18, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number K200389 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2020
Decision Date June 17, 2020
Days to Decision 120 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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