Name: Predicase
Price: 199 USD

K-number	K230292
Device name	Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Applicant	Samsung Electronics Co., Ltd.
Product code	QDA
Device class	Class II
Decision date	May 2, 2023
Decision	Substantially Equivalent
Regulation	870.2345

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Source

View the full FDA submission: accessdata.fda.gov

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Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

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