FDA 510(k) Application Details - K121867

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K121867
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHISON MEDICAL IMAGING CO., LTD.
NO. 8, XIANG NAN ROAD
SHUO FANG, NEW DISTRICT
WUXI 214142 CN
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 06/26/2012
Decision Date 08/02/2012
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 Y
Expedited Review



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