FDA 510(k) Application Details - DEN000001

Device Classification Name Apparatus, Nitric Oxide Delivery

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510(K) Number DEN000001
Device Name Apparatus, Nitric Oxide Delivery
Applicant OHMEDA MEDICAL
P.O. BOX 7550
MADISON, WI 53707-7550 US
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Contact DANIEL KOSEDNAR
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Regulation Number 868.5165

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Classification Product Code MRN
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Date Received 01/07/2000
Decision Date 01/11/2000
Decision DENG -
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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