K-number	K231195
Device name	Brainomix 360 Triage ICH
Applicant	Brainomix Limited
Product code	QAS
Device class	Class II
Decision date	Jul 27, 2023
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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Brainomix 360 Triage ICH

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