INOMAX DS (DELIVERY SYSTEM), MODEL 10003

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), Model 10003.

Pre-market Notification Details

Device IDK080484
510k NumberK080484
Device Name:INOMAX DS (DELIVERY SYSTEM), MODEL 10003
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS 6 ROUTE 173 Clinton,  NJ  08809
ContactDavid Trueblood
CorrespondentDavid Trueblood
INO THERAPEUTICS 6 ROUTE 173 Clinton,  NJ  08809
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 Received2008-02-22
Decision Date2008-08-06
Summary:summary

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