FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K171720 |
AIT Austrian Institute of Technology GmbH |
encevis |
04/19/2018 |
K211452 |
Austrian Institute of Technology GmbH |
Encevis |
12/02/2021 |
K140552 |
CADWELL |
CADWELL SPIKE AND SEIZURE DETECTOR |
07/23/2014 |
K191301 |
Ceribell, Inc. |
Ceribell Pocket EEG Device |
09/11/2019 |
K223504 |
Ceribell, Inc. |
Ceribell Status Epilepticus Monitor |
05/23/2023 |
K010085 |
EXCEL TECH. LTD. |
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) |
03/15/2001 |
K002332 |
EXCEL TECH. LTD. |
EEG SPIKE AND EVENT DETECTOR MODULE |
10/06/2000 |
K042223 |
EXCEL TECH. LTD. |
XLTEK CONNEX IP HEADBOX, MODEL 1054 |
09/16/2004 |
K120260 |
EXCEL-TECH LTD. (XLTEK) |
ICTA |
06/29/2012 |
K222450 |
LVIS Corporation |
LVIS NeuroMatch |
06/09/2023 |
K200878 |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Natus NeuroWorks |
05/18/2020 |
K180421 |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Natus NeuroWorks |
03/14/2018 |
K090019 |
NATUS MEDICAL, INC. |
NATUS NEUROWORKS, MODEL 104196 |
02/22/2010 |
K955787 |
NEW ENGLAND MEDICAL INSTRUMENTS, INC. |
DIGITRACE HOME VIDEO SYSTEM |
02/09/1996 |
K150688 |
OPTIMA NEUROSCIENCE, INC. |
IdentEvent |
11/05/2015 |
K092039 |
OPTIMA NEUROSCIENCE, INC. |
IDENTEVENT, VERSION 1.0G |
10/16/2009 |
K132306 |
PERSYST DEVELOPMENT CORP. |
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE |
11/21/2013 |
K011397 |
PERSYST DEVELOPMENT CORP. |
PERSYST REVEAL |
08/03/2001 |
K133793 |
PERSYST DEVELOPMENT CORPORATION |
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE |
05/19/2014 |
K151929 |
PERSYST DEVELOPMENT CORPORATION |
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE |
08/12/2015 |
K182181 |
Persyst Development Corporation |
Persyst 14 EEG Review and Analysis Software |
11/29/2018 |
K222002 |
Persyst Development Corporation |
Persyst 15 EEG Review and Analysis Software |
12/30/2022 |
K171184 |
Persyst Development Corporation |
Persyst Mobile App |
09/21/2017 |
K141883 |
PICOFEMTO LLC |
CLINISCANSM EEG |
05/15/2015 |
K960273 |
STELLATE SYSTEMS |
HARMONIE SENSA |
04/04/1996 |