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Compumedics Neuvo

FDA UDI

Class II (US FDA UDI)

by Compumedics Limited

Identity

Trade Name
Compumedics Neuvo FDA UDI
Generic Name
Electroencephalograph FDA UDI
Device Name
LTM Module - Neuvo FDA UDI
Model / Reference
Neuvo LTM Module FDA UDI
Description
LTM Module - Neuvo FDA UDI

Identifiers

Catalog Number
9022-0002-01 FDA UDI
Primary DI / UDI-DI
09342451001047 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

Yes

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: Electroencephalograph

Compumedics Neuvo by Compumedics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

Cleared under the same submission

K081151 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compumedics Limited

Sources (1)

  • FDA UDI f94ae2bb-e0ee-43c0-b50e-e68e185acc26 37 fields · synced Jun 6, 2026