INOMAX DSIR (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 Dsir (delivery System).

Pre-market Notification Details

Device IDK130605
510k NumberK130605
Device Name:INOMAX DSIR (DELIVERY SYSTEM)
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS 2902 DAIRY DRIVE Madison,  WI  53718
ContactRobert Bovy
CorrespondentRobert Bovy
INO THERAPEUTICS 2902 DAIRY DRIVE Madison,  WI  53718
Product CodeMRN  
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-07
Decision Date2013-05-02
Summary:summary

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