K-number	K241971
Device name	HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Oct 11, 2024
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

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