FDA 510(k) Application Details - K162055

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K162055
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant EDAN INSTRUMENTS INC
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK
NANHAI RD 1019#
SHENZHEN 518067 CN
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Contact Alice Yang
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/25/2016
Decision Date 01/31/2017
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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