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FDA 510(k)

E3 and Profile

K-Number: K221471 · 2022-11-22

ApplicantDiagnosys, LLC
Decision Date2022-11-22
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

E3 and Profile is a medical device manufactured by Diagnosys, LLC. It received FDA 510(k) clearance on 2022-11-22 under approval number K221471. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E3 and Profile?

E3 and Profile is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Diagnosys, LLC. The 510(k) number is K221471.

When was E3 and Profile approved by the FDA?

E3 and Profile received FDA 510(k) clearance on 2022-11-22, under approval number K221471.

What company makes E3 and Profile?

E3 and Profile is manufactured by Diagnosys, LLC.

What is the FDA product code for E3 and Profile?

The FDA product code for E3 and Profile is GWE.

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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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