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FDA 510(k) Application Details - K162012
Device Classification Name
Display, Cathode-Ray Tube, Medical
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510(K) Number
K162012
Device Name
Display, Cathode-Ray Tube, Medical
Applicant
GE HEALTHCARE
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact
ROBERT CASARSA
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Regulation Number
870.2450
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Classification Product Code
DXJ
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More FDA Info for this Product Code
Date Received
07/21/2016
Decision Date
09/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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