Hypnos (369054-200)— 510(k) K250851

Substantially Equivalent

Cadwell Industries, Inc.

FDA 510(k) clearance K250851 for Hypnos (369054-200), Substantially Equivalent on 2025-12-14. Applicant: Cadwell Industries, Inc.. Device class: 2.

Clearance details

Applicant: Cadwell Industries, Inc.
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-03-21
Decision date: 2025-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, 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.