FC 700 FETAL MONITOR

System, Monitoring, Perinatal

BIONET CO., LTD.

The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Fc 700 Fetal Monitor.

Pre-market Notification Details

Device IDK043597
510k NumberK043597
Device Name:FC 700 FETAL MONITOR
ClassificationSystem, Monitoring, Perinatal
Applicant BIONET CO., LTD. MEDICAL INDUSTRY TECHNO TOWER R205, 1272 MAEJI HEUNGUP Wonju, Kwangwon-do,  KR
ContactSun-young Jeong
CorrespondentSun-young Jeong
BIONET CO., LTD. MEDICAL INDUSTRY TECHNO TOWER R205, 1272 MAEJI HEUNGUP Wonju, Kwangwon-do,  KR
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-29
Decision Date2005-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18809276943597 K043597 000

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