DC-7 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 Dc-7 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK103583
510k NumberK103583
Device Name:DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG. KEJI 12TH RD S. HI-TECH INDUSTRIAL PARK Shenzhen, Guangdong,  CN 518057
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 Received2010-12-07
Decision Date2010-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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06944904001470 K103583 000

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