FDA 510(k) Application Details - K111142

Device Classification Name System, Image Processing, Radiological

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510(K) Number K111142
Device Name System, Image Processing, Radiological
Applicant ECHOMETRIX LLC
2210 WOODHILL WAY
WAUKESHA, WI 53189 US
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Contact LARRY A KROGER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/22/2011
Decision Date 09/21/2012
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 N
Expedited Review



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