INOMAX DS

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.

Pre-market Notification Details

Device IDK071516
510k NumberK071516
Device Name:INOMAX DS
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  
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-04
Decision Date2007-10-03
Summary:summary

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