Definition: Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
| Device Type ID | 3768 |
| Device Name | Index-generating Electroencephalograph Software |
| Physical State | Electroencephalograph Analysis Software, Either Developed By 510(k) Holder For Use In Their Own Hardware Or Licensed From Another Company For Use In 510(k) Holder's Hardware. Does NOT Include Electrodes, Amplitude-integrated Electroencephalograph, Au |
| Technical Method | Uses Software Algorithms, Developed From And Trained With Specific Patient Datasets, To Analyze Electroencephalograph From 1 To 16 Electrodes At Sponsor-specified Locations; Also May Output One Or Several Signal Quality Indicators |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3768 |
| Device | Index-generating Electroencephalograph Software |
| Product Code | OLW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MASIMO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Emits Odor | 2 |
Low Readings | 1 |
No Audible Alarm | 1 |
Smoking | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Aug-30-2018 |