Name: Predicase
Price: 199 USD

K-number	K193147
Device name	Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Applicant	Stereotaxis, Inc.
Product code	PJB
Device class	Class II
Decision date	Mar 5, 2020
Decision	Substantially Equivalent
Regulation	870.5700

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Source

View the full FDA submission: accessdata.fda.gov

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Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

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