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FDA 510(k) Application Details - K161057
Device Classification Name
More FDA Info for this Device
510(K) Number
K161057
Device Name
Diagnostic Imaging Color LCD Monitor
Applicant
NEC DISPLAY SOLUTIONS LTD.
4-28, MITA 1-CHOME, MINATO-KU
TOKYO JP
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Contact
SATORU KOTANI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGY
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More FDA Info for this Product Code
Date Received
04/14/2016
Decision Date
05/13/2016
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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