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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name system, monitoring, for progress of labor
De Novo Number DEN060006
510(K) Number K060028
Device Name COMPUTERIZED LABOR MONITORING SYSTEM
Requester
BARNEV, LTD.
20 hata'as st.
beit hapa'amon (box 124)
kfar saba,  IL 44425
Contact arava hacohen
Regulation Number884.2800
Classification Product Code
NPB  
Date Received10/18/2006
Decision Date 01/30/2007
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
Type Post-NSE
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