CommunicationConsole

FDA UDI

Class II (US FDA UDI)

by Nordicneurolab

Identity

Trade Name: CommunicationConsole FDA UDI
Generic Name: Auditory stimulator FDA UDI
Device Name: CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. FDA UDI
Model / Reference: CC 2.3 FDA UDI
Description: CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. FDA UDI

Identifiers

Primary DI / UDI-DI: 07090042053044 FDA UDI
510(k) Number: K092253 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Auditory stimulator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Auditory stimulator

CommunicationConsole by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K092253 also covers:

Coil Mounted Display — Nordicneurolab
Eye Tracker Camera — Nordicneurolab
Fiberlink transmitter — Nordicneurolab
Headphones — Nordicneurolab
Inroom Viewing Device — Nordicneurolab
LCD Power Supply — Nordicneurolab
LCD Power Supply — Nordicneurolab
Shielded Interface Unit — Nordicneurolab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nordicneurolab

Sources (1)

FDA UDI 85b88f34-6059-41fc-b8a7-db3013369e66 35 fields · synced May 30, 2026