INOMAX DS(IR) (DELIVERY SYSTEM)

Apparatus, Nitric Oxide Delivery

INO THERAPEUTICS LLC/DBA IKARIA

The following data is part of a premarket notification filed by Ino Therapeutics Llc/dba Ikaria with the FDA for Inomax Ds(ir) (delivery System).

Pre-market Notification Details

Device IDK110635
510k NumberK110635
Device Name:INOMAX DS(IR) (DELIVERY SYSTEM)
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen,  LA  70767
ContactLarry Lepley
CorrespondentLarry Lepley
INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen,  LA  70767
Product CodeMRN  
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2011-03-04
Decision Date2011-06-23
Summary:summary

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