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FDA 510(k) Application Details - K042408
Device Classification Name
Chest X-Ray Computer Aided Detection
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510(K) Number
K042408
Device Name
Chest X-Ray Computer Aided Detection
Applicant
EDDA TECHNOLOGY, INC.
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
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Regulation Number
892.2050
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Classification Product Code
OMJ
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More FDA Info for this Product Code
Date Received
09/03/2004
Decision Date
10/08/2004
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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