FDA 510(k) Application Details - K072210

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K072210
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant CHISON MEDICAL IMAGING CO., LTD.
STE 8 ZHONGSHAN MANSION, LANE
999, ZHONGSHAN NO.02 RD (S)
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 08/09/2007
Decision Date 08/24/2007
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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