510(k) K171720
- Device
- Encevis
- Applicant
- AIT Austrian Institute Of Technology GmbH
- 510(k) number
- K171720
- Product code
- OMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-19
- Date received
- 2017-06-12
- Regulation
- 882.1400
- Classification name
- Automatic Event Detection Software For Full-montage Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tilmann Kluge
- Address
- Donau-City-Strabe 1 Vienna AT 1220 1220
FDA Registration Numbers#
- 3007611554
- 3015929663
- 3017374042
- 9612330
- 3010611950
- 8030229
- 2080783
- 2031720
- 3014692331
- 9611252
- 3016852448
- 3013501110
- 3030646118
- 3013671918
Source Documents#
Other 510(k) Records For Product Code OMB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252070 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | 2025-11-21 |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | 2025-10-31 |
| K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | 2025-04-09 |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | 2025-04-09 |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | 2025-01-22 |
| K241390 | NeuroMatch | LVIS Corporation | 2024-11-26 |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024-10-17 |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| K231068 | autoSCORE | Holberg Eeg AS | 2024-01-07 |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024-01-03 |
| K222450 | LVIS NeuroMatch | LVIS Corporation | 2023-06-09 |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023-05-23 |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | 2022-12-30 |
| K211452 | Encevis | Austrian Institute of Technology GmbH | 2021-12-02 |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 |
Legacy Summary#
summary
FDA Review#
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