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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Ultrasonic Transducer, Robotic
510(k) Number K092164
Device Name TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
Applicant
Shenzhen Delicate Electronics Co., Ltd.
1 Odell Plz.
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Shenzhen Delicate Electronics Co., Ltd.
1 Odell Plz.
Yonkers,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number892.1570
Classification Product Code
OQQ  
Subsequent Product Codes
ITX   IYN  
Date Received07/16/2009
Decision Date 05/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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