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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 K080226
Device Name NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
Applicant
Hill-Rom Manufacturing, Inc.
1225 Crescent Green Dr.
Suite 200
Cary,  NC  27511
Applicant Contact DAWN M REILLY
Correspondent
Hill-Rom Manufacturing, Inc.
1225 Crescent Green Dr.
Suite 200
Cary,  NC  27511
Correspondent Contact DAWN M REILLY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/29/2008
Decision Date 04/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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