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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 K091941
Device Name DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg.,Keji 12th Rd. S.,
Hi-Tech Industrial Park
Nanshan, Shenzhen,  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 Codes
IYN   IYO  
Date Received06/30/2009
Decision Date 07/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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