Product code GWF— Neurology
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- Classification name
- Stimulator, Electrical, Evoked Response
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Total cleared
- 141
- First cleared
- Most recent
Clearances under product code GWF — page 2
101–141 of 141- K900482 — SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
- K896567 — CANTATA EMG/EVOKED RESPONSE SYSTEM
- K894608 — MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
- K890274 — MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR
- K885246 — ADVANTAGE
- K884870 — TECA/MEDELEC 'CONCEPT' P420
- K883340 — NEURAL MAGNETIC STIMULATOR, THE D190
- K881915 — DANTEC MAGNETIC STIMULATOR
- K880088 — CADWELL EXCEL
- K870567 — EVOPORT 300
- K871964 — SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
- K872106 — DANTEC COUNTERPOINT
- K871338 — NOVAMETRIX MODEL 200 MAGSTIM
- K863175 — EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
- K862690 — TRAVELER LT
- K861900 — LIFESCAN EVOKED POTENTIAL SYSTEM
- K860968 — TM-3400, NOMAD (MODIFIED)
- K855232 — SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
- K860903 — TM-3600 A NEURODIAGNOSTIC SYSTEM
- K860240 — CNS-EP SYSTEM AND EP 1.0 SOFTWARE
- K851300 — NEUROPACK 8, MEE-4108
- K844992 — BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
- K850109 — NOMAD TM-3400
- K843815 — EVOMATIC 8000/4000
- K844707 — QUANTUM 84
- K843712 — AUDIT TM V
- K842543 — EVOKED POTENTIAL SYS
- K843253 — EMG/NCV & EVOKED RESPONSE, DESIGN W/
- K843464 — SIEGEN NEUROSCOPE
- K831896 — COMPACT FOUR
- K830771 — CADWELL 8400
- K822744 — #ST10 PROGR. EVOKED RESPONSE STIMULATOR
- K822214 — CADWELL 7400
- K822396 — THE 3500
- K820908 — TECA MODEL SENSOR ER 94
- K820414 — UNIVERSAL TESTING & ANALYSIS SYSTEMS
- K811848 — MODEL SIX BEAM SYSTEM
- K810482 — SOMATOSENSORY STIMULATOR
- K810560 — TN-3000 EVOKED RESPONSE SYSTEM
- K781704 — STIMULATOR, TN-3001 SOMATOSENSORY
- K780539 — STIMULATOR MODEL 8021
Data sourced from openFDA. This site is unofficial and independent of the FDA.