Name: Predicase
Price: 199 USD

K-number	K151426
Device name	ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
Applicant	Scandidos AB
Product code	IYE
Device class	Class II
Decision date	Jan 29, 2016
Decision	Substantially Equivalent
Regulation	892.5050

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

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