Identity
- Trade Name
- Compumedics Neuvo FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Neuvo Event Button V2 FDA UDI
- Model / Reference
- Neuvo Event Button V2 FDA UDI
- Description
- Neuvo Event Button V2 FDA UDI
Identifiers
- Catalog Number
- 8022-0018-02 FDA UDI
- Primary DI / UDI-DI
- 09342451001030 FDA UDI
- 510(k) Number
- K081151 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electroencephalograph
Compumedics Neuvo by Compumedics Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
- Natus — Natus Neurology Incorporated · Class II
- Natus — Natus Neurology Incorporated · Class II
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
- WR19 — ZETO INC · Class II
- Grass — Xltek · Class II
Cleared under the same submission
K081151 also covers:
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
- Compumedics Neuvo — COMPUMEDICS LIMITED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Compumedics Limited
Sources (2)
- FDA UDI 9295682f-8058-4e2e-8e58-0472179c0c88 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026