K-number	K102651
Device name	ISCREEN VISION SCREENER
Applicant	Iscreen Vision, Inc.
Product code	HKI
Device class	Class II
Decision date	Jan 12, 2011
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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ISCREEN VISION SCREENER

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