FDA.reportPublic FDA data

OmniPro System

Primary DI
B62536084100
Brand
OmniPro System
Company
Mays & Asscoiates
Model
OmniPro Interface Module
Catalog number
360-8410
Device description
The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050143000OMNIPRO SYSTEMMays and Associates, Inc.2005-02-01OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B62536084100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.5Centimeter
Length15.9Centimeter
Weight390Gram
Width15.6Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6159732027burke.mays@maysinc.net

Regulatory Flags#

DUNS number
101772069
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B62536083000OmniPro SystemOmniAmp EEG Module360-83002019-12-09
B62571883000OmniPro SystemOmniPro EEG System718-83002019-12-09
B62536084000OmniPro SystemOmniAmp PSG Module360-84002019-12-09
B62571884000OmniPro SystemOmniAmp PSG System718-84002019-12-09

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