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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system,network and communication,physiological monitors
510(K) Number K121885
Device Name EARLYSENSE CENTRAL DISPLAY SYSTEM
Applicant
EARLYSENSE LTD.
12 tzvi st
ramat-gan, 
Contact dalia argaman
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/28/2012
Decision Date 09/10/2012
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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