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FDA 510(k)

Rapid PE Triage and Notification (PETN)

K-Number: K220499 · 2022-05-17

ApplicantIschemaview, Inc.
Decision Date2022-05-17
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid PE Triage and Notification (PETN) is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2022-05-17 under approval number K220499. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid PE Triage and Notification (PETN)?

Rapid PE Triage and Notification (PETN) is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Ischemaview, Inc.. The 510(k) number is K220499.

When was Rapid PE Triage and Notification (PETN) approved by the FDA?

Rapid PE Triage and Notification (PETN) received FDA 510(k) clearance on 2022-05-17, under approval number K220499.

What company makes Rapid PE Triage and Notification (PETN)?

Rapid PE Triage and Notification (PETN) is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid PE Triage and Notification (PETN)?

The FDA product code for Rapid PE Triage and Notification (PETN) is QAS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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