Name: Predicase
Price: 199 USD

K-number	K221320
Device name	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
Applicant	Nidek Co., Ltd.
Product code	OBO
Device class	Class II
Decision date	Mar 30, 2023
Decision	Substantially Equivalent
Regulation	886.1570

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Source

View the full FDA submission: accessdata.fda.gov

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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

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