DATEX-OHMEDA INOVENT DELIVERY SYSTEM

Apparatus, Nitric Oxide Delivery

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Inovent Delivery System.

Pre-market Notification Details

Device IDK000186
510k NumberK000186
Device Name:DATEX-OHMEDA INOVENT DELIVERY SYSTEM
ClassificationApparatus, Nitric Oxide Delivery
Applicant DATEX-OHMEDA PO BOX 7550 Madison,  WI  53707
ContactDaniel Kosednar
CorrespondentDaniel Kosednar
DATEX-OHMEDA PO BOX 7550 Madison,  WI  53707
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 Received2000-01-14
Decision Date2000-02-10

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