Delphi Amplifier— 510(k) K243746

Substantially Equivalent

Quantalx Neroscience

FDA 510(k) clearance K243746 for Delphi Amplifier, Substantially Equivalent on 2025-03-12. Applicant: Quantalx Neroscience. Device class: 2.

Clearance details

Applicant: Quantalx Neroscience
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2024-12-05
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Sava, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.