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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(K) Number K121758
Device Name CERNER FETALINK+(VERSION1.0)
Applicant
CERNER CORP.
10234 marion park drive
kansas city,  MO  64137
Contact shelley s looby
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/15/2012
Decision Date 10/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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