OmniPro System

FDA UDI

Class II (US FDA UDI)

by Mays & Asscoiates

Identity

Trade Name: OmniPro System FDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a hospital or diagnostic center. FDA UDI
Model / Reference: OmniAmp EEG Module FDA UDI
Description: The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a hospital or diagnostic center. FDA UDI

Identifiers

Catalog Number: 360-8300 FDA UDI
Primary DI / UDI-DI: B62536083000 FDA UDI
510(k) Number: K050143 FDA UDI
FDA Product Code: GWQ FDA UDI
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Weight — 675 Gram FDA UDI
Height — 3.8 Centimeter FDA UDI
Width — 15.5 Centimeter FDA UDI
Length — 20.5 Centimeter FDA UDI

Category: Electroencephalograph

OmniPro System by Mays & Asscoiates — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

Natus — Natus Neurology Incorporated · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Natus — Natus Neurology Incorporated · Class II
Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
Natus — Natus Neurology Incorporated · Class II
128-channel EEG cap (L) — Megin Oy · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Zeto ONE Head Unit - Small — ZETO INC · Class II

Cleared under the same submission

K050143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mays & Asscoiates

Sources (1)

FDA UDI 79d607cb-2483-48cf-a4a8-8d6e298d1b97 36 fields · synced May 30, 2026