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FDA 510(k) Application Details - K202785
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K202785
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD
Keji 12th Road South, Hi-tech Industrial Park
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Ma chao
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
09/22/2020
Decision Date
04/08/2021
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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