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510(k) K221329

Eyer Retinal Camera NM-STD by Phelcom Technologies — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
May 6, 2022
Clearance Type
Traditional
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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