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FDA 510(k) Application Details - K163443
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K163443
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Interson Corporation
7150 Koll Center Parkway
Pleasanton, CA 94566 US
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Contact
David Asarnow
Other 510(k) Applications for this Contact
Regulation Number
892.1550
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Classification Product Code
IYN
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More FDA Info for this Product Code
Date Received
12/08/2016
Decision Date
04/13/2017
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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