FDA 510(k) Application Details - K130229

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K130229
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD.
ROOM 404, BLDG 7, JINHUICHANG HOMELAND
LIUHONGQIAO RD.
WENZHOU, ZHEJIANG 325000 CN
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Contact HELEN NAN
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 01/29/2013
Decision Date 03/20/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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