FDA product code ORT: Burst Suppression Detection Software For Electroencephalograph
ORT is the FDA product code for burst suppression detection software for electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under ORT. The average 510(k) review took 306 days (median 306).
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.
Classification
| Field | Value |
|---|---|
| Device name | Burst Suppression Detection Software For Electroencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ORT clearance
Top ORT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wavestate, Inc. | 1 | 2010-06-29 |
Most recent ORT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092625 | Wavestate, Inc. | WAVESTATE NEUROMONITOR | 2010-06-29 | 306 |
Recalls for ORT devices
openFDA lists no recalls for product code ORT.
Frequently asked questions
What is FDA product code ORT?
ORT is the FDA product code for burst suppression detection software for electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is ORT?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORT?
Across 1 cleared submissions the average was 306 days from receipt to decision (median 306).
Which companies have the most ORT clearances?
Wavestate, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORT
- Run a recall and safety report across every ORT manufacturer
- Watch product code ORT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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