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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 K043598
Device Name FC 1400 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
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