FDA 510(k) Application Details - K173000

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K173000
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road
Shantou 515041 CN
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Contact Flower Cai
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 09/27/2017
Decision Date 12/07/2017
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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