FDA 510(k) Application Details - K142710

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K142710
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSCAPE COMPANY LIMITED
YIZHE BUILDING, YUQUAN ROAD, NANSHAN
SHENZHEN 518051 TW
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Contact TOKI WU
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 09/22/2014
Decision Date 01/05/2015
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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