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510(k) K162991

YELLOW 560 Fluorescence Module by Carl Zeiss Meditec, AG — Product Code IZI

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 24, 2017
Date Received
October 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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