PERSYST DEVELOPMENT CORP

Address:420 Stevens Avenue,Solana Beach,CA,92075,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Amplitude-Integrated Electroencephalograph (OMA) (5) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (5) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (5)

Premarket Exempt

Clear

Persyst 12 EEG Review and Analysis Software - 00869732000104 Catalog Number :

Device Description : Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.

Device Class : 2

Duns Number: 024168209

Premarket Exempt : No

Product Code : OMA, OMB, OLT

Prescription Use : Yes

Device Count : 1

Persyst 13 EEG Review and Analysis Software - 00869732000111 Catalog Number :

Device Description : Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.

Device Class : 2

Duns Number: 024168209

Premarket Exempt : No

Product Code : OMB, OMA, OLT

Prescription Use : Yes

Device Count : 1

Persyst 14 Review and Analysis Software - 00869732000128 Catalog Number :

Device Description : Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring andtrending of EEG recordings during acquisition and reviewing of processed recordings.

Device Class : 2

Duns Number: 024168209

Premarket Exempt : No

Product Code : OMB, OMA, OLT

Prescription Use : Yes

Device Count : 1

Persyst Mobile App - 00869732000135 Catalog Number :

Device Description : This is an application intended to be used by neurologists who are monitoring or 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.

Device Class : 2

Duns Number: 024168209

Premarket Exempt : No

Product Code : OLT, OMA, OMB

Prescription Use : Yes

Device Count : 1

Persyst Mobile App - 00869732000142 Catalog Number :

Device Class : 2

Duns Number: 024168209

Premarket Exempt : No

Product Code : OMB, OLT, OMA

Prescription Use : Yes

Device Count : 1

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