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FDA 510(k) Application Details - K160807
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K160807
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
PHILIPS ULTRASOUND, INC.
3000 MINUTEMAN ROAD
ANDOVER, MA 01810 US
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Contact
PENG CUI
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
03/24/2016
Decision Date
04/06/2016
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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