Definition: Automatically Mark Or Identify Electroencephalograph Waveforms For Rhythmic Patterns Of Burst Suppression In Order To Aid In Identification Of Such Events And Help In The Review And Annotation Of Prolonged EEG Traces; Software Can Also Quantify Simpl
| Device Type ID | 3776 |
| Device Name | Burst Suppression Detection Software For 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), Automatic Event (i.e., Seizure) Detection So |
| Technical Method | Uses Simple, Transparent Software Algorithms To Analyze Any Size Montage (full Or Reduced) For Burst Suppression Patterns And Automatically Identify Areas Of Interest Or Quantify Pattern Characteristics. |
| 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 | ORT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3776 |
| Device | Burst Suppression Detection Software For Electroencephalograph |
| Product Code | ORT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Device Problems | |
|---|---|
Smoking | 1 |
| Total Device Problems | 1 |