ORT · Burst Suppression Detection Software For Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | ORT |
|---|---|
| Device Name | Burst Suppression Detection Software For Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092625 | WAVESTATE NEUROMONITOR | Wavestate, Inc. | Jun 29, 2010 | SESE |
Top Applicants
- Wavestate, Inc. — 1 clearance
