Name: Predicase
Price: 199 USD

K-number	K223670
Device name	MESI mTablet ECG Diagnostic System, MESI mTablet ECG
Applicant	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Product code	DPS
Device class	Class II
Decision date	Jul 28, 2023
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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MESI mTablet ECG Diagnostic System, MESI mTablet ECG

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