Identity
- Trade Name
- Persyst 12 EEG Review and Analysis Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- Persyst 12 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
- P12 FDA UDI
- Description
- Persyst 12 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
- 00869732000104 FDA UDI
- 510(k) Number
- K133793 FDA UDI
- FDA Product Code
- OMA FDA UDIOMB FDA UDIOLT FDA UDI
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Bioelectrical signal analysis software
Persyst 12 EEG Review and Analysis Software by Persyst Development LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Persyst Development LLC
Sources (1)
- FDA UDI 3e8dbe16-d2a2-4239-a5be-43557c5f359c 35 fields · synced Jun 9, 2026