INOMAX DS (DELIVERY SYSTEM)

Ventilatory Effort Recorder

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).

Pre-market Notification Details

Device IDK090958
510k NumberK090958
Device Name:INOMAX DS (DELIVERY SYSTEM)
ClassificationVentilatory Effort Recorder
Applicant INO THERAPEUTICS LLC 2902 DAIRY DR. Madison,  WI  53718
ContactDavid Trueblood
CorrespondentDavid Trueblood
INO THERAPEUTICS LLC 2902 DAIRY DR. Madison,  WI  53718
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-06
Decision Date2009-06-18
Summary:summary

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