Name: Predicase
Price: 199 USD

K-number	K121628
Device name	EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
Applicant	Epi Mobile Health Solutions (S) Pte, Ltd.
Product code	DXH
Device class	Class II
Decision date	Jun 25, 2013
Decision	Substantially Equivalent
Regulation	870.2920

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Source

View the full FDA submission: accessdata.fda.gov

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EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)

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