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510(k) K213527

FORUM by Carl Zeiss Meditec, AG — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2022
Date Received
November 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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