DEVICE: Persyst 13 EEG Review and Analysis Software (00869732000111)
Device Identifier (DI) Information
Persyst 13 EEG Review and Analysis Software
P13
In Commercial Distribution
Persyst Development Corp
P13
In Commercial Distribution
Persyst Development Corp
Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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47541 | Bioelectrical signal analysis software |
A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.
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FDA Product Code
[?]Product Code | Product Code Name |
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OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph |
OMA | Amplitude-Integrated Electroencephalograph |
OLT | Non-Normalizing Quantitative Electroencephalograph Software |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151929 | 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
3ae4072f-443a-469a-a0a7-21e618e0740d
July 14, 2023
5
September 01, 2016
July 14, 2023
5
September 01, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(928) 708-0705
support@persyst.com
support@persyst.com