E-CUBE 7

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 7.

Pre-market Notification Details

Device IDK132687
510k NumberK132687
Device Name:E-CUBE 7
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 Received2013-08-28
Decision Date2013-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800013510037 K132687 000
08800013510105 K132687 000
08800013511003 K132687 000
08800013511010 K132687 000
08800013512000 K132687 000
08800013513007 K132687 000
08800013513014 K132687 000
08800013513038 K132687 000
08800013513045 K132687 000
08800013514011 K132687 000
08800013521002 K132687 000
08800013510006 K132687 000

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