Identity
- Trade Name
- Ives EEG Solutions FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible FDA UDI
- Model / Reference
- DCPE-21/S FDA UDI
- Description
- MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850012681045 FDA UDI
- 510(k) Number
- K071118 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Analytical scalp electrode, single-use
Ives EEG Solutions by Ives EEG Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analytical scalp electrode, single-use.
- Cadwell Single Disc Electrode — Cadwell Industries, Inc. · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Cadwell EEG Gold Cup Electrode — Cadwell Industries, Inc. · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Neuroline Cup — Ambu A/S · Class II
- Zeto ONE Short-Term Electrode Set — ZETO INC · Class II
- BRAINSTREAM — Conmed Corporation · Class II
Cleared under the same submission
K071118 also covers:
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
- Ives EEG Solutions — Ives EEG Solutions
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
- Ives EEG Solutions
Sources (1)
- FDA UDI 984c6994-f260-404d-af85-510ee3f7a8dd 35 fields · synced May 30, 2026