DeviceClearance

Product code ORT— Neurology

WAVESTATE NEUROMONITOR

Classification name
Burst Suppression Detection Software For Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code ORT under 21 CFR 882.1400, via openFDA

Market context for product code ORT

FDA has cleared 1 device under product code ORT, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ORT

Recent clearances under product code ORT

Data sourced from openFDA. This site is unofficial and independent of the FDA.