E-CUBE 12

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 12.

Pre-market Notification Details

Device IDK142884
510k NumberK142884
Device Name:E-CUBE 12
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul,  KR 152-848
ContactDonghwan Kim
CorrespondentDonghwan Kim
ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul,  KR 152-848
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-02
Decision Date2014-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800013524003 K142884 000

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