SomniCheck— 510(k) K223676

Substantially Equivalent

Brainmatterz, LLC

FDA 510(k) clearance K223676 for SomniCheck, Substantially Equivalent on 2023-06-01. Applicant: Brainmatterz, LLC. Device class: 2.

Clearance details

Applicant: Brainmatterz, LLC
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2022-12-08
Decision date: 2023-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, TX, 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.