Name: Predicase
Price: 199 USD

K-number	K233853
Device name	LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
Applicant	Philips Medical Systems Nederland B.V.
Product code	DQK
Device class	Class II
Decision date	Mar 14, 2024
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

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