FDA 510(k) Application Details - K173369

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K173369
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen 518057 CN
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Contact Jean Lei
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 10/27/2017
Decision Date 12/13/2017
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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