Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX— 510(k) K221320

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K221320 for Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX, Substantially Equivalent on 2023-03-30. Applicant: Nidek Co., Ltd..

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2022-05-06
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

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