E3 and Profile— 510(k) K221471

Substantially Equivalent

Diagnosys, LLC

FDA 510(k) clearance K221471 for E3 and Profile, Substantially Equivalent on 2022-11-22. Applicant: Diagnosys, LLC. Device class: 2.

Clearance details

Applicant: Diagnosys, LLC
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2022-05-20
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, 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.