K-number	K220499
Device name	Rapid PE Triage and Notification (PETN)
Applicant	Ischemaview, Inc.
Product code	QAS
Device class	Class II
Decision date	May 17, 2022
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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Rapid PE Triage and Notification (PETN)

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