Name: Predicase
Price: 199 USD

K-number	K062149
Device name	SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
Applicant	International Business Strategies
Product code	DQA
Device class	Class II
Decision date	May 31, 2007
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES

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