FDA 510(k) Application Details - K052113

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K052113
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 08/04/2005
Decision Date 08/09/2005
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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