DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900

Transducer, Ultrasonic, Diagnostic

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 Digital Ultrasonic Diagnostic Imaging System, Model Dp-6900.

Pre-market Notification Details

Device IDK090912
510k NumberK090912
Device Name:DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG,KEJI 12TH RD. S. HI-TECH INDUSTRIAL PARK Nanshan, Shenzhen, Guangdong,  CN 518057
ContactTan Chuanbin
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-04-01
Decision Date2009-04-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904089096 K090912 000
06944904089089 K090912 000
06944904034119 K090912 000
06944904019758 K090912 000
06944904018454 K090912 000
06944904001449 K090912 000

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