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I-Portal Super VNG

FDA UDI

Class II (US FDA UDI)

by N K I

Identity

Trade Name
I-Portal Super VNG FDA UDI
Generic Name
Diagnostic caloric vestibular stimulation system FDA UDI
Device Name
Video-Nystagmograph FDA UDI
Model / Reference
SVNG FDA UDI
Description
Video-Nystagmograph FDA UDI

Identifiers

Catalog Number
SVNG FDA UDI
Primary DI / UDI-DI
B290SVNG1 FDA UDI
510(k) Number
K143607 FDA UDI
FDA Product Code
GWN FDA UDI
GMDN Term
Diagnostic caloric vestibular stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic caloric vestibular stimulation system

I-Portal Super VNG by N K I — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic caloric vestibular stimulation system.

Cleared under the same submission

K143607 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
N K I

Sources (1)

  • FDA UDI cf072a12-dc07-4c4a-a0e2-7efa05e1dbe3 35 fields · synced May 30, 2026