Z5 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 Z5 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK130695
510k NumberK130695
Device Name:Z5 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, Guangdong,  CN 518057
ContactWu Zicui
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 Received2013-03-14
Decision Date2013-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904089416 K130695 000
06944904054094 K130695 000
06944904042039 K130695 000
06944904037301 K130695 000
06944904037165 K130695 000
06944904017914 K130695 000
06944904017891 K130695 000
06944904001586 K130695 000
06944904001579 K130695 000

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