Identity
- Trade Name
- Power-LAN Connection Box USB FDA UDI
- Generic Name
- Evoked-potential graphic recording system FDA UDI
- Device Name
- Interface for EMG/EP Amplifier FDA UDI
- Model / Reference
- B9700070100 FDA UDI
- Description
- Interface for EMG/EP Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900253 FDA UDI
- 510(k) Number
- K073415 FDA UDI
- FDA Product Code
- JXE FDA UDIGWJ FDA UDIGWF FDA UDIIKN FDA UDI
- GMDN Term
- Evoked-potential graphic recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1550 FDA UDI882.1900 FDA UDI882.1870 FDA UDI890.1375 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
Yes
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
Yes
FDA UDI
Category: ElectromyographEvoked-potential graphic recording system
Power-LAN Connection Box USB by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073415 also covers:
- Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA
- Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz — EB NEURO SPA
- Manipolo di Stimolazione Elettrica — EB NEURO SPA
- Manipolo di Stimolazione Elettrica 2+ — EB NEURO SPA
- NeMus 1 — EB NEURO SPA
- NeMus 1 — EB NEURO SPA
- Power-LAN Connection Box — EB NEURO SPA
- R-KEY (Dedicated Keyboard) — EB NEURO SPA
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
- Eb Neuro Spa
Sources (1)
- FDA UDI 01b9af6c-50ac-4db5-88cc-c3692f3e7be3 35 fields · synced May 30, 2026