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FDA 510(k) Application Details - K040589
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K040589
Device Name
Oximeter
Applicant
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS, MN 55447-4755 US
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Contact
JOHN R DALPEE
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/08/2004
Decision Date
06/03/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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