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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K121013
Model 6300,6400,6500,6700,6800
Device Name CONNEX VITAL SIGNS MONITOR 6000 SERIES
Original Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 0220
Original Contact kevin crossen
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/03/2012
Decision Date 07/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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