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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K122247
Model HM 81
Device Name LIDCORAPID V2 MONITOR
Original Applicant
LIDCO LTD.
16 orsman rd.
london,  UK n15qj
Original Contact gregory speller
Regulation Number870.1435
Classification Product Code
DXG  
Subsequent Product Code
GWQ  
Date Received07/27/2012
Decision Date 03/20/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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