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

Automatic Event Detection Software For Full-Montage Electroencephalograph

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

OMB is the FDA product code for Automatic Event Detection Software For Full-Montage Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user". As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OMB
Device name
Automatic Event Detection Software For Full-Montage Electroencephalograph
FDA definition
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by 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
No
Ingested clearances
42
Ingested recalls
1

Clearances, product code OMB

By decision year
42 clearances under product code OMB with a decision year between 1987 and 2026, 2024 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code OMB by decision year
YearClearances
19871
19911
19954
19962
20001
20012
20041
20091
20101
20121
20131
20142
20153
20171
20183
20191
20201
20211
20221
20232
20245
20255
20261

Applicants with the most clearances

Product code OMB
Applicants holding the most 510(k) clearances under product code OMB
ApplicantClearances
Persyst Development LLC9
Ceribell, Inc.5
Excel Tech., Ltd.3
Ait Austrian Institute of Technology GmbH2
Bio-Logic Systems Corp.2
Epitel2
Holberg EEG AS2
Lvis Corporation2
Natus Medical Incorporated2
New England Medical Instruments, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order