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FDA 510(k) Application Details - K210068
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K210068
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Samsung Medison CO., LTD.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun 25108 KR
Other 510(k) Applications for this Company
Contact
Scully Kim
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
01/11/2021
Decision Date
04/09/2021
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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