FDA 510(k) Application Details - K091374

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K091374
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant GE MEDICAL SYSTEMS CHINA CO., LTD.
NO. 19 CHANGJIANG ROAD
NATIONAL HI-TECH DEV. ZONE
WUXI, JIANGSU PROVINCE 214028 CN
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Contact YALAN WU
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 05/11/2009
Decision Date 05/26/2009
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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