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FDA 510(k) Application Details - K171766
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K171766
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
Siemens Medical Solutions Inc.
685 East Middlefield Road
Mountain View, CA 94043 US
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Contact
Kevin Kong
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
06/14/2017
Decision Date
07/12/2017
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
Y
Expedited Review
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