Identity
- Trade Name
- Headphones FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Head Phones 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 is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. FDA UDI
- Model / Reference
- HP 1.3 FDA UDI
- Description
- Head Phones 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 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
- 07090042053013 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Auditory stimulator
Headphones 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:
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 1b97e242-4a9b-4914-a3f8-8e9996e480ce 35 fields · synced May 30, 2026