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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name apparatus, nitric oxide delivery
De Novo Number DEN000001
510(K) Number K974562
Device Name OHMEDA INOVENT DELIVERY SYSTEM
Requester
ohmeda medical
p.o. box 7550
madison,  WI  53707 -7550
Contact daniel kosednar
Regulation Number868.5165
Classification Product Code
MRN  
Date Received01/07/2000
Decision Date 01/11/2000
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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