Name: Predicase
Price: 199 USD

K-number	K200737
Device name	SPY Portable Handheld Imaging (SPY-PHI) System
Applicant	Novadaq Technologies Ulc. (Now A Part of Stryker)
Product code	OWN
Device class	Class II
Decision date	May 21, 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 Portable Handheld Imaging (SPY-PHI) System

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