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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, for progress of labor
510(k) Number K082704
Device Name BIRTHTRACK (A.K.A. CLM)
Applicant
BARNEV, LTD.
20 HATA'AS ST.
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
BARNEV, LTD.
20 HATA'AS ST.
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number884.2800
Classification Product Code
NPB  
Date Received09/16/2008
Decision Date 01/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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