SomniCheck
FDA 510(k) clearance K223676 · decided 2023-06-01
Clearance details
- K-number
- K223676
- Device name
- SomniCheck
- Applicant
- Brainmatterz, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-12-08
- Decision date
- 2023-06-01
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GWL
- Device class
- 2
- Regulation number
- 882.1835
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Richmond, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Brainmatterz
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Delphi Amplifier (K243746) | Quantalx Neroscience | 2025-03-12 |
| NExT Station; NExT Station Advanced (K242832) | Eb Neuro S.P.A. | 2024-12-12 |
| BE Plus PRO, Neurotravel LIGHT (K242305) | Eb Neuro S.P.A. | 2024-09-04 |
| DreamClear (K240646) | Somnomed Technologies Inc., Doing Business AS Remware | 2024-09-04 |
| X-trodes System M (K232210) | X-Trodes | 2024-02-04 |
| Vlab (K230148) | Dormotech Medical, Ltd. | 2023-10-11 |
| NomadAir PMU810 (K220631) | Neurotronics, Inc. | 2022-07-15 |
| Quick-20m (K203331) | Cgx, LLC | 2021-05-20 |
| Digital NeuroPort Biopotential Signal Processing System (K202174) | Blackrock Microsystems | 2021-02-10 |
| 8-CH Electroencephalography Amplifier (K201747) | Hipposcreen Neurotech Corp. | 2020-12-27 |
| eego amplifiers (K172312) | Eemagine Medical Imaging Solutions GmbH | 2018-03-30 |
| Sienna Ultimate Wireless Amplifier (K171397) | Ems Handels Gesellschaft M.B.H. | 2017-10-06 |
Recalls involving this device
No recalls on record reference this clearance.