Persyst 14 EEG Review and Analysis Software
FDA 510(k) K182181 · Persyst Development Corporation
510(k) numberK182181
Submission
- Device name
- Persyst 14 EEG Review and Analysis Software
- Applicant
- Persyst Development Corporation
Solana Beach, CA, US - Received
- August 13, 2018
- Decision date
- November 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OMB – Automatic Event Detection Software For Full-Montage Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Other 510(k)s with product code OMB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260998 | Ceribell Neurology Review SoftwareOMB · Traditional | Ceribell, Inc. | 06/24/2026SE |
| K252070 | Ceribell Infant Seizure Detection SoftwareOMB · Traditional | Ceribell, Inc. | 11/21/2025SE |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | Persyst Development, LLC | 10/31/2025SE |
| K243743 | autoSCORE (V 2.0.0)OMB · Traditional | Holberg Eeg AS | 04/09/2025SE |
| K241589 | Ceribell Seizure Detection SoftwareOMB · Traditional | Ceribell, Inc. | 04/09/2025SE |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | Persyst Development Corporation | 01/22/2025SE |
| K241390 | NeuroMatchOMB · Traditional | LVIS Corporation | 11/26/2024SE |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM)OMB · Traditional | Epitel, Inc. | 10/17/2024SE |
| K240993 | encevis (2.1)OMB · Traditional | Ait Austrian Institute of Technology GmbH | 09/27/2024SE |
| K231068 | autoSCOREOMB · Traditional | Holberg Eeg AS | 01/07/2024SE |
More from Holberg Eeg AS
| 510(k) | Device | Decision |
|---|---|---|
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | 10/31/2025SE |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | 01/22/2025SE |
| K222002 | Persyst 15 EEG Review and Analysis SoftwareOMB · Traditional | 12/30/2022SE |
| K171184 | Persyst Mobile AppOMB · Traditional | 09/21/2017SE |
| K151929 | Persyst 13 (P13) EEG Review and Analysis SoftwareOMB · Special | 08/12/2015SE |
| K133793 | Persyst 12 ( P12) Egg Review and Analysis SoftwareOMB · Traditional | 05/19/2014SE |
| K132306 | Persyst 12 EEG Review and Analysis SoftwareOMB · Traditional | 11/21/2013SE |
| K103103 | Presson ElectrodeGXZ · Traditional | 12/08/2011SE |
| K011397 | Persyst RevealOMB · Traditional | 08/03/2001SE |
| K974718 | Persyst PrismGWS · Traditional | 03/09/1998SE |
Questions and answers
When was Persyst 14 EEG Review and Analysis Software cleared by the FDA?
Persyst 14 EEG Review and Analysis Software (K182181) received a 510(k) decision of Substantially Equivalent on November 29, 2018, 108 days after the submission was received.
What is the product code of K182181?
The FDA product code is OMB – Automatic Event Detection Software For Full-Montage Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.