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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 K110556
Device Name MINI TELEMETRY SYSTEM
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GOMAN ROAD
LAUREL,  MD  20723 -5800
Applicant Contact AGATA SMIEJA
Correspondent
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GOMAN ROAD
LAUREL,  MD  20723 -5800
Correspondent Contact AGATA SMIEJA
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/28/2011
Decision Date 07/19/2011
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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