INOmax DSIR Plus

Apparatus, Nitric Oxide Delivery

Mallinckrodt Manufacturing LLC

The following data is part of a premarket notification filed by Mallinckrodt Manufacturing Llc with the FDA for Inomax Dsir Plus.

Pre-market Notification Details

Device IDK200389
510k NumberK200389
Device Name:INOmax DSIR Plus
ClassificationApparatus, Nitric Oxide Delivery
Applicant Mallinckrodt Manufacturing LLC 6603 Femrite Drive Madison,  WI  53718
ContactDavid Trueblood
CorrespondentJamie Yieh
Mallinckrodt Hospital Products Inc. 1425 U.S. Route 206 Bedminster,  NJ  07921
Product CodeMRN  
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-06-17

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