Name: Predicase
Price: 199 USD

K-number	K202244
Device name	SPY-PHI System with SPY-PHI Fluorescence Assessment Software
Applicant	Novadaq Technologies Ulc. (Now A Part of Stryker)
Product code	OWN
Device class	Class II
Decision date	Nov 5, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SPY-PHI System with SPY-PHI Fluorescence Assessment Software

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