Fiberlink transmitter

FDA UDI

Class II (US FDA UDI)

by Nordicneurolab

Identity

Trade Name: Fiberlink transmitter FDA UDI
Generic Name: Laser adaptor FDA UDI
Device Name: Fiberlink transmitter is part of NordicNeuroLab’s fMRI System. Fiberlink transmitter converts audio and video signals into an optical signal for transmission. Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System. FDA UDI
Model / Reference: FLT 2.1 FDA UDI
Description: Fiberlink transmitter is part of NordicNeuroLab’s fMRI System. Fiberlink transmitter converts audio and video signals into an optical signal for transmission. Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System. FDA UDI

Identifiers

Primary DI / UDI-DI: 07090042055017 FDA UDI
510(k) Number: K092253 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Laser adaptor 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: Laser adaptor

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

Similar devices

Also classified as Laser adaptor.

Accu-Beam — Transamerican Technologies International · Class II
Accu-Beam — Transamerican Technologies International · Class II
Accu-Beam — Transamerican Technologies International · Class II
SUPRASCAN 577nm — QUANTEL MEDICAL · Class II
Alcon — Alcon Laboratories, Inc. · Class II
Accu-Beam — Transamerican Technologies International · Class II
LightScalpel — LIGHTSCALPEL INC · Class II
532nm adaptor for CSO 980 Slit Lamp — QUANTEL MEDICAL · Class II

Cleared under the same submission

K092253 also covers:

Coil Mounted Display — Nordicneurolab
CommunicationConsole — Nordicneurolab
Eye Tracker Camera — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nordicneurolab

Sources (1)

FDA UDI 538c33d6-9f16-4fe9-bac7-ce7203b8dd57 35 fields · synced May 30, 2026