X4 System
by Advanced Brain Monitoring, Inc.
510(k) K130013
X4 System is a Class II device made by Advanced Brain Monitoring, Inc., cleared under FDA 510(k) K130013 on 31 Jan 2013, 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 | NumberK130013 | Date31 Jan 2013 | StatusActive |
Official records
- FDA 510(k) database K130013
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- Withdrawn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 K130013
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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