Polysmith Sleep System
510(k) K142774
Polysmith Sleep System is a Class II device made by Neurotronics, Inc., cleared under FDA 510(k) K142774 on 18 Feb 2015, 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 | NumberK142774 | Date18 Feb 2015 | StatusActive |
Official records
- FDA 510(k) database K142774
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLV
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142774
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 | |||
|---|---|---|---|---|
| Sphinx CU710 Control Unit | CU710 | 00817111020205 | — | On the market |
| Sphinx HB710 Head Box | HB710 | 00817111020335 | — | On the market |
Similar devices
Other devices filed under FDA product code OLV (Standard Polysomnograph With Electroencephalograph).
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- CEEGRAPH/SLEEPSCAN NETLINK TRAVELER by Bio-Logic Systems Corp.
- Onera STS 01.00 by Onera B.V.
- NIGHTRON POLYSOMNOGRAPHY SYSTEM by Telediagnostic Systems, Inc.
- GRASS BRAINWAVE SOFTWARE by Astro-Med, Inc.
- Comet-PLUS by NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)