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 Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center FDA UDI
Model / Reference: OmniPro Interface Module FDA UDI
Description: The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center FDA UDI

Identifiers

Catalog Number: 360-8410 FDA UDI
Primary DI / UDI-DI: B62536084100 FDA UDI
510(k) Number: K050143 FDA UDI
FDA Product Code: GWQ FDA UDI
OLV 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 — 390 Gram FDA UDI
Height — 4.5 Centimeter FDA UDI
Width — 15.6 Centimeter FDA UDI
Length — 15.9 Centimeter FDA UDI

Category: Polysomnograph Electroencephalograph

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

Similar devices

Also classified as Electroencephalograph.

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Natus — Natus Neurology Incorporated · Class II
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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 83e5db3c-2414-4c14-97bc-6c0b42846f6b 37 fields · synced May 30, 2026