ResponseGrip Interface

Primary DI
07090042054027
Brand
ResponseGrip Interface
Company
Nordicneurolab AS
Model
2.0
Device description
ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PCThe ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
Published
2017-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092253000MODIFICATION TO FMRI HARDWARE SYSTEMNordicneurolab2009-10-08LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090042054027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090042054027070900420540277090042054027

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4755707095customerservice@nordicneurolab.com

Regulatory Flags#

DUNS number
671280238
Device count
1
Serial number
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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07090042053068HeadSet 3T1.02026-04-01
07090042053075BatteryCharger1.02026-04-01
07090042053082AccessPoint1.02026-04-01
07090042053099AudioHub1.02026-04-01
07090042052122Visual System Power SupplyVPS-1.22025-04-04
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07090042052078VisualSystem Power Cable (VPC)1.12021-01-29
07090042052108Visual System HDVHD-1.22021-01-29
07090042052061Control Room InterfaceCRI-1.02020-03-01
07090042052085Visual System HDVHD-1.12020-03-01
07090042052092Visual System Power SupplyVPS-1.12020-03-01
07090042054041ResponseGrip InterfaceRGI-2.22019-10-24
07090042054058SyncBoxSB- 3.22019-10-24
07090042051057LCD Power SupplyLPS-3.12019-06-27
07090042051033Inroom Viewing DeviceLDC 3.02016-09-24
07090042051040LCD Power SupplyLPS 3.02016-09-24
07090042052016Coil Mounted DisplayCMD 2.32016-09-24
07090042052023Eye Tracker CameraETC 2.02017-12-31
07090042053013HeadphonesHP 1.32016-09-24

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