Identity
- Trade Name
- ResponseGrip Interface FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC The 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. FDA UDI
- Model / Reference
- 2.0 FDA UDI
- Description
- ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC The 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042054027 FDA UDI
- 510(k) Number
- K092253 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Medical networking interface unit 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
ResponseGrip Interface 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 3d036bc8-7285-4486-9674-e7161de83a2d 36 fields · synced Jun 8, 2026