E-CUBE 9

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 9.

Pre-market Notification Details

Device IDK120060
510k NumberK120060
Device Name:E-CUBE 9
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ALPINION MEDICAL SYSTEMS CO., LTD 10604 NE 38TH PLACE SUITE 229 Kirkland,  WA  98033
ContactYuchi Chu
CorrespondentYuchi Chu
ALPINION MEDICAL SYSTEMS CO., LTD 10604 NE 38TH PLACE SUITE 229 Kirkland,  WA  98033
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-09
Decision Date2012-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800013522009 K120060 000

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