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FDA 510(k) Application Details - K000186
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K000186
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
DATEX-OHMEDA
PO BOX 7550
MADISON, WI 53707 US
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Contact
DANIEL KOSEDNAR
Other 510(k) Applications for this Contact
Regulation Number
868.5165
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Classification Product Code
MRN
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More FDA Info for this Product Code
Date Received
01/14/2000
Decision Date
02/10/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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