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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K910629
Device Name AP-860PA NIBP MODULE
Original Applicant
NIHON KOHDEN AMERICA, INC.
17112 armstrong ave.
irvine,  CA  92714
Original Contact mike dashefsky
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/13/1991
Decision Date 05/14/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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