FDA 510(k) Application Details - K150002

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K150002
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SASET (CHENGDU) INC.
A-601, Huoju Building, #16 Chuangye Rd
B Hi-Tech Avenue, Hi-Tech Zone
CHENGDU 610041 CN
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Contact Dong Chyuan Liu
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 01/02/2015
Decision Date 06/23/2015
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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