E-CUBE 8

System, Imaging, Pulsed Doppler, Ultrasonic

ALPINION MEDICAL SYSTEMS Co., Ltd.

The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for E-cube 8.

Pre-market Notification Details

Device IDK172732
510k NumberK172732
Device Name:E-CUBE 8
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ALPINION MEDICAL SYSTEMS Co., Ltd. 1FL And 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul,  KR 08393
ContactBoyeon Cho
CorrespondentBoyeon Cho
ALPINION MEDICAL SYSTEMS Co., Ltd. 1FL And 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul,  KR 08393
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-11
Decision Date2017-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800013512093 K172732 000
08800013528001 K172732 000
08800013514035 K172732 000
08800013511119 K172732 000

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