Cleared Traditional

DreamClear

K240646 · Somnomed Technologies Inc., Doing Business AS Remware · Neurology
Sep 2024
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K240646 is an FDA 510(k) clearance for the DreamClear, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Somnomed Technologies Inc., Doing Business AS Remware (Tampa, US). The FDA issued a Cleared decision on September 4, 2024, 181 days after receiving the submission on March 7, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K240646 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2024
Decision Date September 04, 2024
Days to Decision 181 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835