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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 K014094
Device Name MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Applicant
HILL-ROM MANUFACTURING, INC.
11000 REGENCY PKWY.
WEST TOWER, SUITE 205
CARY,  NC  27511
Applicant Contact CINDY L CROSBY
Correspondent
HILL-ROM MANUFACTURING, INC.
11000 REGENCY PKWY.
WEST TOWER, SUITE 205
CARY,  NC  27511
Correspondent Contact CINDY L CROSBY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/12/2001
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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