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Persyst 15 EEG Review and Analysis Software
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref None
Identity
- Trade Name
- Persyst 15 EEG Review and Analysis Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- Persyst 15 EEG Review and Analysis Software EUDAMEDPersyst 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. FDA UDI
- Model / Reference
- None EUDAMEDP15 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869732000166 EUDAMEDFDA UDI
- Basic UDI-DI
- 869732000166JJ EUDAMED
- Direct Marketing DI
- 00869732000166 EUDAMED
- 510(k) Number
- K222002 FDA UDI
- FDA Product Code
- OMB FDA UDIOMA FDA UDIOLT FDA UDI
- EMDN Code
- Z12100392 ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Persyst 15 EEG Review and Analysis Software by Persyst Development LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222002 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252160 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242446 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 869732000166JJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Persyst Development LLC
- EUDAMED SRN
- US-MF-000036728
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 80ed9162-14cd-4df0-b429-bc4800972e33 61 fields · synced Jul 9, 2026
- FDA UDI c8ce9b05-4205-4d01-b8a1-53c05f161a52 35 fields · synced May 30, 2026
- FDA 510(k) K222002 1 fields · synced May 18, 2026