RemLogic
510(k) K162140
RemLogic is a Class II device made by Embla Systems, cleared under FDA 510(k) K162140 on 1 Dec 2016, 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 | NumberK162140 | Date1 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K162140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).
- SOMNUM (SOMNUM) by Honeynaps Co., Ltd.
- EnsoSleep by Ensodata, Inc.
- Sensor Medics 4000 Series Sleep System by Sensor Medics Corp.
- Sleepware G3 Software, Multi-Lingual - 3 1082463 by Respironics Inc.
- Sleepware G3 by Respironics, Inc.
- Sleep Analysis Module by Neurotronics, LLC
- NEAT 001 by Brain Electrophysiology Laboratory Company, LLC
- DeepRESP by Nox Medical
- SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 by Omega Results
- SomnoMetry by Neumetry Medical, Inc.