Name: Predicase
Price: 199 USD

K-number	K193473
Device name	LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Applicant	Boston Scientific Corporation
Product code	MXD
Device class	Class II
Decision date	Jun 26, 2020
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

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