FDA 510(k) Application Details - K101041

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K101041
Device Name Transducer, Ultrasonic, Diagnostic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH RD
SOUTH, HI-TECH INDUSTRIAL PARK
NANSHAN,SHENZHEN, P.R. CHINA 518057 CN
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Contact MENG XIANJUN
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 04/14/2010
Decision Date 04/30/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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