Name: Predicase
Price: 199 USD

K-number	K063730
Device name	DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
Applicant	Volume Interactions Pte, Ltd.
Product code	LLZ
Device class	Class II
Decision date	Jan 31, 2007
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0

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