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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
Applicant Contact SHELLEY S LOOBY
Correspondent
CERNER CORP.
10234 MARION PARK DRIVE
KANSAS CITY,  MO  64137
Correspondent Contact SHELLEY S LOOBY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/15/2012
Decision Date 10/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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