ORT — Burst Suppression Detection Software For Electroencephalograph Class II
FDA product code ORT covers "Burst Suppression Detection Software For Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ORT
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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 simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092625 | wavestate | WAVESTATE NEUROMONITOR | June 29, 2010 |