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
00869732000111
GS1

1
159514244 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
OMA Amplitude-Integrated Electroencephalograph
OLT Non-Normalizing Quantitative Electroencephalograph Software
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151929 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3ae4072f-443a-469a-a0a7-21e618e0740d
July 14, 2023
5
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Customer Contact

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(928) 708-0705
support@persyst.com
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