FDA 510(k)

E3 and Profile

K-Number: K221471 · 2022-11-22

Decision Date2022-11-22

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

E3 and Profile is the device name listed in this FDA 510(k) record. The listed applicant is Diagnosys, LLC. It received FDA 510(k) clearance on 2022-11-22 under 510(k) 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. The listed applicant is Diagnosys, LLC. The 510(k) number is K221471.

When did E3 and Profile receive FDA 510(k) clearance?

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

Who is the listed applicant for E3 and Profile?

The FDA 510(k) record lists Diagnosys, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E3 and Profile?

The FDA product code for E3 and Profile is GWE.

Related Devices (Code: GWE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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