FDA.reportPublic FDA data

Persyst Mobile App

Primary DI
00869732000142
Brand
Persyst Mobile App
Company
Persyst Development Corp
Model
App for Web
Device description
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Published
2019-04-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMAAmplitude-Integrated Electroencephalograph
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171184000Persyst Mobile AppPersyst Development Corporation2017-09-21OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869732000142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869732000142008697320001428697320001420869732000142

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19287080705support@persyst.com

Regulatory Flags#

DUNS number
159514244
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869732000166Persyst 15 EEG Review and Analysis SoftwareP152023-07-24
00869732000135Persyst Mobile App Persyst Mobile App2019-04-08
00869732000128Persyst 14 Review and Analysis SoftwareP142019-04-08
00869732000104Persyst 12 EEG Review and Analysis SoftwareP122016-09-01
00869732000111Persyst 13 EEG Review and Analysis SoftwareP132016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.OLT2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAOLT2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAOLT2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAOLT2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAOLT2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28