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FDA 510(k) Application Details - K182175
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K182175
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Atys
17, Parc D'arbora
Soucieu En Jarrest 69510 FR
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Contact
Christine Turlat
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
08/10/2018
Decision Date
04/05/2019
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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