INO THERAPEUTICS 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 Ino Therapeutics Inomax Ds (delivery System), Model 10003.

Pre-market Notification Details

Device IDK061901
510k NumberK061901
Device Name:INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
ClassificationApparatus, Nitric Oxide Delivery
Applicant INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton,  WI  53562
ContactFrederick Montgomery
CorrespondentFrederick Montgomery
INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton,  WI  53562
Product CodeMRN  
Subsequent Product CodeMRO
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-05
Decision Date2006-12-14
Summary:summary

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