Name: Predicase
Price: 199 USD

K-number	K182907
Device name	SPY Elite Intraoperative Perfusion Assessment System
Applicant	Novadaq Technologies Ulc. (Now A Part of Stryker)
Product code	IZI
Device class	Class II
Decision date	Jan 23, 2019
Decision	Substantially Equivalent
Regulation	892.1600

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Source

View the full FDA submission: accessdata.fda.gov

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SPY Elite Intraoperative Perfusion Assessment System

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