Identity
- Trade Name
- HeadPhones Slim FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Head Phones Slim 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. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. FDA UDI
- Model / Reference
- HPS 1.0 FDA UDI
- Description
- Head Phones Slim 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. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042053020 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
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
HeadPhones Slim by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092253 also covers:
- Coil Mounted Display — Nordicneurolab
- CommunicationConsole — 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 092c99ae-b7a8-4ad9-be93-20d067b91df4 36 fields · synced May 31, 2026