K-number	K232962
Device name	Patient Monitor (iX10, iX12, iX15)
Applicant	Edan Instruments, Inc.
Product code	MHX
Device class	Class II
Decision date	Apr 19, 2024
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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Patient Monitor (iX10, iX12, iX15)

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