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

Amplitude-Integrated Electroencephalograph

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

OMA is the FDA product code for Amplitude-Integrated Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner)". As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
OMA
Device name
Amplitude-Integrated Electroencephalograph
FDA definition
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
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
16
Ingested recalls
3

Clearances, product code OMA

By decision year
16 clearances under product code OMA with a decision year between 1979 and 2020, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OMA by decision year
YearClearances
19791
19991
20031
20071
20082
20102
20121
20132
20151
20162
20171
20201

Applicants with the most clearances

Product code OMA
Applicants holding the most 510(k) clearances under product code OMA
ApplicantClearances
Nihon Kohden America Inc2
Nihon Kohden Corp.2
Olympic Medical Corp.2
Applied Medical Research1
Astro-Med, Inc.1
Brainz Instruments, Ltd.1
Cadwell Industries Inc1
Eemagine Medical Imaging Solutions GmbH1
Excel-Tech Ltd. (Xltek)1
Mennen Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order