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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 K043597
Device Name FC 700 FETAL MONITOR
Applicant
Bionet Co., Ltd.
Medical Industry Techno Tower
R205, 1272 Maeji Heungup
Wonju, Kwangwon-Do,  KR
Applicant Contact SUN-YOUNG JEONG
Correspondent
Bionet Co., Ltd.
Medical Industry Techno Tower
R205, 1272 Maeji Heungup
Wonju, Kwangwon-Do,  KR
Correspondent Contact SUN-YOUNG JEONG
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/29/2004
Decision Date 12/16/2005
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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