R-40 EEG Amplifier— 510(k) K151600

Substantially Equivalent

Lifelines , Ltd.

FDA 510(k) clearance K151600 for R-40 EEG Amplifier, Substantially Equivalent on 2015-10-23. Applicant: Lifelines , Ltd.. Device class: 2.

Clearance details

Applicant: Lifelines , Ltd.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2015-06-12
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Over Wallop, GB

Download summary PDF View on FDA.gov ↗

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