DEVICE: Natus (00382830022309)
Device Identifier (DI) Information
Natus
015418
In Commercial Distribution
XLTEK
015418
In Commercial Distribution
XLTEK
Neuroworks/Sleepworks 8.1.0 (International) software
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Electroencephalograph | A line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K090019 | 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
429ebb22-c7d4-4794-b157-95c5e370c0b5
July 06, 2018
3
September 13, 2016
July 06, 2018
3
September 13, 2016
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
[?]
No Customer Contact currently defined