SignalNED System (Model RE)— 510(k) K251726

Name: FDA 510(k) clearance K251726
Creator: U.S. Food and Drug Administration
Published: 2025-09-03

Substantially Equivalent

Forest Devices, Inc.

FDA 510(k) clearance K251726 for SignalNED System (Model RE), Substantially Equivalent on 2025-09-03. Applicant: Forest Devices, Inc.. Device class: 2.

Clearance details

Applicant: Forest Devices, Inc.
Product code: Code OMC
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-06-05
Decision date: 2025-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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