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FDA 510(k) Application Details - K210699
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K210699
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech
Industrial Park
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Hao Yixuan
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2021
Decision Date
06/10/2021
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
N
Expedited Review
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