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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 K112687
Device Name CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 0220
Contact kevin crossen
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/15/2011
Decision Date 11/22/2011
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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