DEVICE: Compumedics Okti (09342451002211)
Device Identifier (DI) Information
Compumedics Okti
Okti 64
In Commercial Distribution
8029-0003-01
COMPUMEDICS LIMITED
Okti 64
In Commercial Distribution
8029-0003-01
COMPUMEDICS LIMITED
Okti 64 Channel Acquisition Module
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11467 | Electroencephalograph |
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
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Active | false |
35163 | Electroencephalographic ambulatory recorder |
A portable electrically-powered device designed for recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders; it is not intended for inpatient monitoring. It is a small unit designed to be worn by the patient with an appropriate signal amplifier, and intended to be used with a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) data is analysed after the recording period using an appropriate computer/software.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWQ | Full-Montage Standard Electroencephalograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K230073 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
412a1177-eb49-49a4-9d92-02b70063ce9b
June 21, 2023
1
June 13, 2023
June 21, 2023
1
June 13, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61384207386
support@compumedics.com.au 1-877-294-1346
support@compumedicsusa.com
support@compumedics.com.au 1-877-294-1346
support@compumedicsusa.com