Name: Predicase
Price: 199 USD

K-number	K213467
Device name	EVA NEXUS Ophthalmic Surgical System
Applicant	D.O.R.C. Dutch Ophthalmic Research Center (International)
Product code	HQC
Device class	Class II
Decision date	Jun 14, 2022
Decision	Substantially Equivalent
Regulation	886.4670

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Source

View the full FDA submission: accessdata.fda.gov

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EVA NEXUS Ophthalmic Surgical System

Everything you need for a 510(k) submission. Nothing you don't.