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510(k) K243600

3nethra neo HD FA; 3nethra neo HD by Forus Health Pvt.Ltd — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2025
Date Received
November 21, 2024
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

Other clearances by Forus Health Pvt.Ltd

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