DeviceClearance

Product code OLZ— Neurology

DeepRESP

Classification name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
37
First cleared
Most recent

FDA classification definition

“Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user”

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

Market context for product code OLZ

FDA has cleared 37 devices under product code OLZ between 1986 and 2026, filed by 24 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code OLZ

Recent clearances under product code OLZ

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