Name: Predicase
Price: 199 USD

K-number	K223918
Device name	AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Applicant	Philips Medical Systems Nederland B.V.
Product code	DQK
Device class	Class II
Decision date	Jun 8, 2023
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

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