Visual System Power Supply - Visual System Power Supply (VPS) for - Nordicneurolab AS

Duns Number:671280238

Device Description: Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HDShielded enclosure c Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HDShielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Visual System Power Supply

Version/Model Number

VPS-1.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191032

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

7f5c0151-0f8f-47a0-b472-4c802d307ddb

Public Version Date

June 02, 2020

Public Version Number

2

DI Record Publish Date

March 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORDICNEUROLAB AS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24