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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 K091251
Device Name CERNER FETALINK (VERSION 1.0)
Applicant
Cerner Corp.
2800 Rockcreek Pkwy.
Kansas City,  MO  64117
Applicant Contact SHELLEY S LOOBY
Correspondent
Cerner Corp.
2800 Rockcreek Pkwy.
Kansas City,  MO  64117
Correspondent Contact SHELLEY S LOOBY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/29/2009
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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