MEDIP PRO

System, Image Processing, Radiological

MEDICALIP Co., Ltd

The following data is part of a premarket notification filed by Medicalip Co., Ltd with the FDA for Medip Pro.

Pre-market Notification Details

Device IDK191026
501k NumberK191026
Device Name:MEDIP PRO
ClassificationSystem, Image Processing, Radiological
Applicant MEDICALIP Co., Ltd 7F Changkyung Building, 174, Yulgok-ro Jongno-gu,  KR 03127
ContactYoon Bo Chung
CorrespondentGeumhyeon Kim
DT&S Co., Ltd. #202, Mario Tower, 28, Digital-ro 30-gil Guro-gu,  KR 08389
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-18
Decision Date2019-11-07

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.