DreamClear— 510(k) K240646

Name: FDA 510(k) clearance K240646
Creator: U.S. Food and Drug Administration
Published: 2024-09-04

Substantially Equivalent

Somnomed Technologies Inc., Doing Business AS Remware

FDA 510(k) clearance K240646 for DreamClear, Substantially Equivalent on 2024-09-04. Applicant: Somnomed Technologies Inc., Doing Business AS Remware. Device class: 2.

Clearance details

Applicant: Somnomed Technologies Inc., Doing Business AS Remware
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2024-03-07
Decision date: 2024-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.