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FDA 510(k) Application Details - K200655
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K200655
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
Echosens
6 rue Ferrus
Paris 75014 FR
Other 510(k) Applications for this Company
Contact
Karine Bonenfant
Other 510(k) Applications for this Contact
Regulation Number
892.1560
More FDA Info for this Regulation Number
Classification Product Code
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2020
Decision Date
07/16/2020
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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