ETD4000— 510(k) K202725

Substantially Equivalent

Therasigma, LLC

FDA 510(k) clearance K202725 for ETD4000, Substantially Equivalent on 2021-03-26. Applicant: Therasigma, LLC. Device class: 2.

Clearance details

Applicant: Therasigma, LLC
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2020-09-17
Decision date: 2021-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washougal, WA, 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.