Scrambler Therapy Technology (Model ST-5A)— 510(k) K201458

Name: FDA 510(k) clearance K201458
Creator: U.S. Food and Drug Administration
Published: 2020-12-23

Substantially Equivalent

Delta International Services & Logistics S.R.L

FDA 510(k) clearance K201458 for Scrambler Therapy Technology (Model ST-5A), Substantially Equivalent on 2020-12-23. Applicant: Delta International Services & Logistics S.R.L. Device class: 2.

Clearance details

Applicant: Delta International Services & Logistics S.R.L
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2020-06-01
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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