K-number	K230074
Device name	Rapid Aneurysm Triage and Notification
Applicant	Ischemaview, Inc.
Product code	QFM
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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Rapid Aneurysm Triage and Notification

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