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510(k) K241049

CANON Fundus Camera CR-10 (CR-10) by Canon, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2024
Date Received
April 17, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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