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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 K102263
Device Name HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
Applicant
MCKESSON INFORMATION SOLUTIONS LLC
1835 MARKET ST. 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact STEVEN B DATLOF
Correspondent
MCKESSON INFORMATION SOLUTIONS LLC
1835 MARKET ST. 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact STEVEN B DATLOF
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/10/2010
Decision Date 05/05/2011
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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