M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M7/m7t Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK103677
510k NumberK103677
Device Name:M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BLDG.A3,HONG HUA LING IND.PARK NORTH, LIU XIAN ROAD,XILI TOWN Nanshan,shenzhen, Guangdong,  CN 518055
ContactZhai Pei
CorrespondentJeff D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-12-16
Decision Date2011-01-31
Summary:summary

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