Product code OMB— Neurology
Natus NeuroWorks
- Advisory panel
- Neurology
- Total cleared
- 42
Recent clearances under product code OMB
- K260998 — Ceribell Neurology Review Software
- K252070 — Ceribell Infant Seizure Detection Software
- K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K241589 — Ceribell Seizure Detection Software
- K243743 — autoSCORE (V 2.0.0)
- K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K241390 — NeuroMatch
- K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM)
- K240993 — encevis (2.1)
- K231068 — autoSCORE
- K231779 — REMI AI Discrete Detection Module
- K222450 — LVIS NeuroMatch
- K223504 — Ceribell Status Epilepticus Monitor
- K222002 — Persyst 15 EEG Review and Analysis Software
- K211452 — Encevis
- K200878 — Natus NeuroWorks
- K191301 — Ceribell Pocket EEG Device
- K182181 — Persyst 14 EEG Review and Analysis Software
- K171720 — encevis
- K180421 — Natus NeuroWorks
- K171184 — Persyst Mobile App
- K150688 — IdentEvent
- K151929 — PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
- K141883 — CLINISCANSM EEG
- K140552 — CADWELL SPIKE AND SEIZURE DETECTOR
- K133793 — PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
- K132306 — PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
- K120260 — ICTA
- K090019 — NATUS NEUROWORKS, MODEL 104196
- K092039 — IDENTEVENT, VERSION 1.0G
- K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054
- K011397 — PERSYST REVEAL
- K010085 — EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
- K002332 — EEG SPIKE AND EVENT DETECTOR MODULE
- K960273 — HARMONIE SENSA
- K955787 — DIGITRACE HOME VIDEO SYSTEM
- K951594 — BIO-LOGIC AUTOMATIC EVENT ANALYSIS
- K950270 — NMI SOFTWARE
- K944833 — DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
- K950117 — PERSYST SPIKE DETECTOR
- K910771 — DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
- K870450 — SZAC-16 SEIZURE ANALYSIS COMPUTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.