DreamClear
FDA 510(k) K240646 · Somnomed Technologies Inc., Doing Business AS Remware
510(k) numberK240646
Submission
- Device name
- DreamClear
- Applicant
- Somnomed Technologies Inc., Doing Business AS Remware
Tampa, FL, US - Received
- March 7, 2024
- Decision date
- September 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243746 | Delphi AmplifierGWL · Traditional | Quantalx Neroscience | 03/12/2025SE |
| K242832 | NExT Station; NExT Station AdvancedGWL · Special | Eb Neuro S.P.A. | 12/12/2024SE |
| K242305 | BE Plus PRO, Neurotravel LIGHTGWL · Special | Eb Neuro S.P.A. | 09/04/2024SE |
| K232210 | X-trodes System MGWL · Traditional | X-Trodes | 02/04/2024SE |
| K230148 | VlabGWL · Traditional | Dormotech Medical, Ltd. | 10/11/2023SE |
| K223676 | SomniCheckGWL · Traditional | Brainmatterz, LLC | 06/01/2023SE |
| K220631 | NomadAir PMU810GWL · Traditional | Neurotronics, Inc. | 07/15/2022SE |
| K203331 | Quick-20mGWL · Traditional | Cgx, LLC | 05/20/2021SE |
| K202174 | Digital NeuroPort Biopotential Signal Processing SystemGWL · Special | Blackrock Microsystems | 02/10/2021SE |
| K201747 | 8-CH Electroencephalography AmplifierGWL · Traditional | Hipposcreen Neurotech Corp. | 12/27/2020SE |
Questions and answers
When was DreamClear cleared by the FDA?
DreamClear (K240646) received a 510(k) decision of Substantially Equivalent on September 4, 2024, 181 days after the submission was received.
What is the product code of K240646?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.