CUBEScan BioCon-1100

System, Imaging, Pulsed Echo, Ultrasonic

Mcube Technology Co., Ltd.

The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan Biocon-1100.

Pre-market Notification Details

Device IDK201995
510k NumberK201995
Device Name:CUBEScan BioCon-1100
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro, Jungnang-gu Seoul,  KR 02048
ContactHye-ri Choi
CorrespondentHye-ri Choi
Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro, Jungnang-gu Seoul,  KR 02048
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-20
Decision Date2020-08-19

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