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510(k) K231075

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) by Carl Zeiss Meditec, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2023
Date Received
April 14, 2023
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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