FDA.reportPublic FDA data

I-Portal Portable Assessment System

Primary DI
B290IPAS0
Brand
I-Portal Portable Assessment System
Company
N K I
Model
IPAS
Catalog number
IPAS
Device description
Nystagmograph
Published
2018-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B290IPAS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Caloric vestibular-stimulation systemAn assembly of devices intended to apply heat stimuli in the form of a stream of air or water into the ear canal. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. The stimulation of the semicircular canal produces involuntary eye movements (nystagmus) which are measured using a nystagmograph. It is used for vestibular function testing for assessing the patient's balance system. This device is typically used in an ear/nose/throat (ENT) department.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151391174
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B290NOTC0Neuro Kinetics IncNOTCNOTC2017-02-13
B290SVNG0I-Portal Super VNGSVNGSVNG2017-01-13
B290SVNG1I-Portal Super VNGSVNGSVNG2017-01-02

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00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
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08054187380983VNGINVENTIS SRLGWN2024-10-01
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00763000467340NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26