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

Reduced- Montage Standard Electroencephalograph

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

OMC is the FDA product code for Reduced- Montage Standard Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes". As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OMC
Device name
Reduced- Montage Standard Electroencephalograph
FDA definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
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
29
Ingested recalls
0

Clearances, product code OMC

By decision year
29 clearances under product code OMC with a decision year between 1978 and 2026, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OMC by decision year
YearClearances
19781
19971
20001
20023
20042
20061
20101
20111
20121
20131
20141
20151
20171
20191
20201
20211
20221
20232
20243
20253
20261

Applicants with the most clearances

Product code OMC
Applicants holding the most 510(k) clearances under product code OMC
ApplicantClearances
Advanced Brain Monitoring, Inc.3
Cleveland Medical Devices, Inc.3
Epitel3
Ceribell, Inc.2
Forest Devices, Inc.2
Oxford Biosignals Limited2
Byteflies NV1
Cyberkinetics, Inc.1
Jordan Neuroscience, Inc.1
Mennen Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order