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FDA 510(k) Application Details - K170537
Device Classification Name
Display, Cathode-Ray Tube, Medical
More FDA Info for this Device
510(K) Number
K170537
Device Name
Display, Cathode-Ray Tube, Medical
Applicant
Barco n.v.
Beneluxpark 21
Kortrijk 8500 BE
Other 510(k) Applications for this Company
Contact
Eric Caus
Other 510(k) Applications for this Contact
Regulation Number
870.2450
More FDA Info for this Regulation Number
Classification Product Code
DXJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2017
Decision Date
04/21/2017
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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