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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 K050234
Device Name REMOTE CARE
Applicant
E.Care Solutions, Inc.
6740 Riverview Ter.
Minneapolis,,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
E.Care Solutions, Inc.
6740 Riverview Ter.
Minneapolis,,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/01/2005
Decision Date 08/25/2005
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
Predetermined Change
Control Plan Authorized		 No
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