Definition: Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged EEG Traces; All Output Subject To Ver
| Device Type ID | 3773 |
| Device Name | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Physical State | Electroencephalograph Analysis Software. Does NOT Include Electrodes, Electroencephalograph Hardware, Basic Electroencephalograph Software (e.g. Used To Display, Store, Archive, Or Manually Annotate Data), Or Automatic Event Detection Software Used A |
| Technical Method | Uses Software Algorithms To Analyze Full-montage Electroencephalograph (16 Electrodes) At User-specified Locations And Automatically Identify Areas Of Interest. |
| 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 | OMB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3773 |
| Device | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Product Code | OMB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CADWELL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTIMA NEUROSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PERSYST DEVELOPMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
PICOFEMTO LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 1 |
| Total Device Problems | 1 |