X4
by Advanced Brain Monitoring, Inc.
510(k) K120447
X4 is a Class II device made by Advanced Brain Monitoring, Inc., cleared under FDA 510(k) K120447 on 20 Jun 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120447 | Date20 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120447
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OMC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K120447
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sleep Profiler SP40-4101 | SP40-4101 | 00851113007215 | — | On the market |
| Sleep Profiler SP40-4225.1 | SP40-4225.1 | 00851113007222 | — | On the market |
| Sleep Profiler SP40-4305 | SP40-4305 | 00851113007239 | — | On the market |
| X-Series, X8 UN03-4004 | UN03-4004 | 00851113007161 | — | On the market |
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- REMI Remote EEG Monitoring System by Epitel, Inc.
- BIOSOMNIA by Oxford Biosignals Limited