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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K090912
Device Name DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BLDG,KEJI 12TH RD. S.
HI-TECH INDUSTRIAL PARK
NANSHAN, SHENZHEN, GUANGDONG,  CN 518057
Applicant Contact TAN CHUANBIN
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYO  
Date Received04/01/2009
Decision Date 04/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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