Name: Predicase
Price: 199 USD

K-number	K142398
Device name	Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
Applicant	Ellex Medical Pty, Ltd.
Product code	HQF
Device class	Class II
Decision date	Jul 14, 2015
Decision	Substantially Equivalent
Regulation	886.4390

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow

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