INOMAX DS (DELIVERY SYSTEM), MODEL 10003

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), Model 10003.

Pre-market Notification Details

Device IDK070867
510k NumberK070867
Device Name:INOMAX DS (DELIVERY SYSTEM), MODEL 10003
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS LLC 6 ROUTE 173 Clinton,  NJ  08809
ContactRichard K Bourne
CorrespondentRichard K Bourne
INO THERAPEUTICS LLC 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 Received2007-03-29
Decision Date2007-04-27
Summary:summary

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