K-number	K230184
Device name	Holter ECG and ABP System
Applicant	Edan Instruments, Inc.
Product code	DSH
Device class	Class II
Decision date	Sep 25, 2023
Decision	Substantially Equivalent
Regulation	870.2800

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View the full FDA submission: accessdata.fda.gov

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Holter ECG and ABP System

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