DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SONOSCAPE COMPANY LIMITED

The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Digital Color Doppler Ultrasound System.

Pre-market Notification Details

Device IDK131213
510k NumberK131213
Device Name:DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSCAPE COMPANY LIMITED YIZHE BLDG., YUQUAN RD Shenzhen, Guangdong,  CN 518051
ContactToki Wu
CorrespondentToki Wu
SONOSCAPE COMPANY LIMITED YIZHE BLDG., YUQUAN RD Shenzhen, Guangdong,  CN 518051
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-29
Decision Date2013-06-21
Summary:summary

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