Name: Predicase
Price: 199 USD

K-number	K133686
Device name	21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)
Applicant	Jvckenwood Corporation
Product code	LLZ
Device class	Class II
Decision date	Jan 6, 2014
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)

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