INOMAX DS (DELIVERY SYSTEM)

Apparatus, Nitric Oxide Delivery

INO THERAPEUTICS LLC

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

Pre-market Notification Details

Device IDK081691
510k NumberK081691
Device Name:INOMAX DS (DELIVERY SYSTEM)
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS LLC 2820 WALTON COMMONS WEST Madison,  WI  53718
ContactDavid Trueblood
CorrespondentDavid Trueblood
INO THERAPEUTICS LLC 2820 WALTON COMMONS WEST Madison,  WI  53718
Product CodeMRN  
Subsequent Product CodeMRO
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-17
Decision Date2008-08-28
Summary:summary

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