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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K083505
Device Name DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd.
South, Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact TAN CHAUNBIN
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/26/2008
Decision Date 12/12/2008
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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