510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OLUClass II

Normalizing Quantitative Electroencephalograph Software

21 CFR 882.1400 / Neurology
FDA source (opens on fda.gov)

OLU is the FDA product code for Normalizing Quantitative Electroencephalograph Software, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OLU
Device name
Normalizing Quantitative Electroencephalograph Software
FDA definition
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
0

Clearances, product code OLU

By decision year
13 clearances under product code OLU with a decision year between 1991 and 2026, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OLU by decision year
YearClearances
19911
19981
20041
20051
20121
20141
20181
20202
20232
20241
20261

Applicants with the most clearances

Product code OLU
Applicants holding the most 510(k) clearances under product code OLU
ApplicantClearances
Applied Neuroscience, Inc.1
Brainmaster Technologies, Inc.1
Brc Operations Pty Limited1
Corscience GmbH & Co. KG1
Eiminda, Ltd.1
Elminda, Ltd.1
G.tec Medical Engineering GmbH1
Medeia Inc1
Neurofield, Inc.1
Nxlink, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code