K-number	K232496
Device name	Brainomix 360 Triage Stroke
Applicant	Brainomix Limited
Product code	QAS
Device class	Class II
Decision date	Nov 21, 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 Stroke

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