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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, tissue saturation
510(K) Number K112826
Model MOORVMS-OXY
Device Name NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
Applicant
MOOR INSTRUMENTS LTD.
millwey
axminster, devon, 
Contact xiabing huang huang
Regulation Number870.2700
Classification Product Code
MUD  
Date Received09/28/2011
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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