← Back to catalogue

Compumedics Okti

FDA UDI

Class II (US FDA UDI)

by Compumedics Limited

Identity

Trade Name
Compumedics Okti FDA UDI
Generic Name
Electroencephalograph FDA UDI
Device Name
Okti 128 Channel Acquisition Module FDA UDI
Model / Reference
Okti 128 FDA UDI
Description
Okti 128 Channel Acquisition Module FDA UDI

Identifiers

Catalog Number
8029-0004-01 FDA UDI
Primary DI / UDI-DI
09342451002228 FDA UDI
510(k) Number
K230073 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ElectroencephalographElectroencephalographic ambulatory recorder

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

Similar devices

Also classified as Electroencephalographic ambulatory recorder.

Cleared under the same submission

K230073 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Compumedics Limited

Sources (1)

  • FDA UDI bcc57ea2-fa5c-4fba-8a4c-d438e76076c8 36 fields · synced Jun 1, 2026