INOMAX DS (DELIVERY SYSTEM)

Apparatus, Nitric Oxide Delivery

INO THERAPEUTICS

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

Pre-market Notification Details

Device IDK121021
510k NumberK121021
Device Name:INOMAX DS (DELIVERY SYSTEM)
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS 2902 DAIRY DRIVE Madison,  WI  53718
ContactDavid Trueblood
CorrespondentDavid Trueblood
INO THERAPEUTICS 2902 DAIRY DRIVE Madison,  WI  53718
Product CodeMRN  
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-04
Decision Date2012-09-24
Summary:summary

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