Rapid PE Triage and Notification (PETN)— 510(k) K220499

Name: FDA 510(k) clearance K220499
Creator: U.S. Food and Drug Administration
Published: 2022-05-17

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K220499 for Rapid PE Triage and Notification (PETN), Substantially Equivalent on 2022-05-17. Applicant: Ischemaview, Inc.. Device class: 2.

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2022-02-22
Decision date: 2022-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.