AccessGUDID - DEVICE: Persyst 15 EEG Review and Analysis Software (00869732000166)

GUDID

Device Identifier (DI) Information

Brand Name: Persyst 15 EEG Review and Analysis Software
Version or Model: P15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Persyst Development Corp

Primary DI Number: 00869732000166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 159514244 *Terms of Use

Device Description: Persyst 15 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
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 [?]
K222002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8ce9b05-4205-4d01-b8a1-53c05f161a52
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023