FDA 510(k) Application Details - K043597

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K043597
Device Name System, Monitoring, Perinatal
Applicant BIONET CO., LTD.
MEDICAL INDUSTRY TECHNO TOWER
R205, 1272 MAEJI HEUNGUP
WONJU, KWANGWON-DO KR
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Contact SUN-YOUNG JEONG
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 12/29/2004
Decision Date 12/16/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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