K-number	K213057
Device name	ExamVue Duo
Applicant	Jpi Healthcare Co, Ltd.
Product code	KPR
Device class	Class II
Decision date	Feb 18, 2022
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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ExamVue Duo

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