Genesis Sleep— 510(k) K252951

Substantially Equivalent

Neurofield, Inc.

FDA 510(k) clearance K252951 for Genesis Sleep, Substantially Equivalent on 2025-12-31. Applicant: Neurofield, Inc.. Device class: 2.

Clearance details

Applicant: Neurofield, Inc.
Product code: Code QJQ
Device class: Class 2
Regulation: 21 CFR 882.5800
Advisory panel: Neurology
Date received: 2025-09-16
Decision date: 2025-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.