FDA.reportPublic FDA data

OmniPro System

Primary DI
B62571884000
Brand
OmniPro System
Company
Mays & Asscoiates
Model
OmniAmp PSG System
Catalog number
718-8400
Device description
OmniPro PSG System used in PSG physiological data collection
Published
2019-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard 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
B62571884000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

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
B62536084100OmniPro SystemOmniPro Interface Module360-84102019-12-09
B62571883000OmniPro SystemOmniPro EEG System718-83002019-12-09
B62536084000OmniPro SystemOmniAmp PSG Module360-84002019-12-09

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