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FDA 510(k) Application Details - K111142
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
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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