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FDA 510(k) Application Details - K101041
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
MENG XIANJUN
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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