What is FDA product code OMC?

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

AE-120A EEG Head Set · Reduced- Montage Standard Electroencephalograph → Neurology

Name: AE-120A EEG Head Set
Brand: AE-120A EEG Head Set

3manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OMC
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for AE-120A EEG Head Set
Listed by	Nihon Kohden Corp., Japan
FDA product code	OMC
Device type	Reduced- Montage Standard Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Specification developer, Manufacturer
Record published	2019-06-13
Record revised	2024-04-15 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for AE-120A EEG Head Set
Catalogue number	Size	Status
YZ-003A4		In distribution
AE-120A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
X-Series	Advanced Brain Monitoring, Inc.	59
Sleep Profiler PSG2	Advanced Brain Monitoring, Inc.	22
Sleep Profiler	Advanced Brain Monitoring, Inc.	13
Remi	Epitel	12
Natus	Xltek	5
Narcotrend Patient lead	MT Monitortechnik Gmbh & Co. KG	2
Reduced- Montage Standard Electroencephalograph	GE Healthcare Finland OY	2
Quex S	QX World KFT	2
VitalEEG Portable System	Nihon Kohden America, Inc.	2
Nurochek-Pro	Headsafe MFG PTY Ltd	2
Quex ED	QX World KFT	2
Global Reference Module 4	Neuralynx, Inc.	1

Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183529	2019-03-19

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

AE-120A EEG Head Set