FDA.reportPublic FDA data

Evoked-potential graphic recording system

Definition
An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.
GUDID devices
155
Last updated
2026-07-17 21:59:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.M998920S2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.M0131532026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.M998920D2026-06-10
00817020020068eABR Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.M0131522016-09-24
00817020020075USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.M0103002016-09-24
00817020020808SmartEP SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8110002016-09-24
00817020020013EarHug PackINTELLIGENT HEARING SYSTEMS CORP.M0154022016-09-24
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.M0111602024-03-11
00851641007183EPADSAFEOP SURGICAL, INC.EPAD2016-12-14
00851641007190EPADSAFEOP SURGICAL, INC.EPAD2016-12-14
00851641007206EPADSAFEOP SURGICAL, INC.EPAD2017-06-09
00860009695221Innara HealthINNARA HEALTH, INC.IN-50022022-11-03
00860009695238Innara HealthINNARA HEALTH, INC.IN-50032022-11-03
00860009695245Innara HealthINNARA HEALTH, INC.IN-50042022-10-27
00860009695252Innara HealthINNARA HEALTH, INC.M000452022-10-27
00860009695269Innara HealthINNARA HEALTH, INC.M000462022-10-27
07290018971017DELPHI-MD System DeviceQUANTALX NEUROSCIENCE LTD12026-05-05
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAB97000910002025-05-22
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTD Nurochek-Pro Headset Assembly (HS03-267)2026-03-18
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDNurochek-Pro Kit (HS03-369) rev 22026-01-23
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDNurochek-Pro Kit (HS03-369) rev 12025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTD Nurochek-Pro Headset Assembly (HS03-267)2025-12-15
09357225002021Nurochek-Pro Application HEADSAFE MFG PTY LTDNurochek-Pro Application (HS03-303)2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDNurochek-Pro Server (HS03-304)2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDNurochek-Pro Soft Sensor Kit (HS03-313)2025-12-15
09357225006029Nurochek-Pro Saline SolutionHEADSAFE MFG PTY LTDSaline Solution Bottle Assembly (HS03-368)2025-12-15
08056446900338NeMus 2 600EB NEURO SPAB98000666012025-05-26
08056446900345NeMus 2 700EB NEURO SPAB98000667012025-05-26
08056446900352NeMus 2 +EB NEURO SPAB98000668012025-05-26
00860009695207Innara HealthINNARA HEALTH, INC.IN-50002022-11-03
00860009695214Innara HealthINNARA HEALTH, INC.IN-50012022-11-03
10860009695228Innara HealthINNARA HEALTH, INC.IN-50022022-11-03
10860009695235Innara HealthINNARA HEALTH, INC.IN-50032022-11-03
10860009695242Innara HealthINNARA HEALTH, INC.IN-50042022-10-27
10860009695259Innara HealthINNARA HEALTH, INC.M000452022-10-27
10860009695266Innara HealthINNARA HEALTH, INC.M000462022-10-27
10885380195556NTRAINERINNARA HEALTH, INC.510NT2023-07-03
10885380195587NTRAINERCardinal Health 200, LLC1000NT2023-07-03
00196852124213Innara HealthINNARA HEALTH, INC.IN-50002022-11-03
00196852125432Innara HealthINNARA HEALTH, INC.IN-50012022-11-03
10196852173638Innara HealthINNARA HEALTH, INC.IN-50022022-11-03
10196852668189Innara HealthINNARA HEALTH, INC.IN-50032022-11-03
00841983104251Neuropack S3NIHON KOHDEN AMERICA, INC.NPS3-LT-Cart2-ZA2020-07-20
00841983104268Neuropack S3NIHON KOHDEN AMERICA, INC.NPS3-LT-Cart4-ZA2020-07-20
00873263008119Resident Expert Kinetic Testing Motion DetectorFHC, INC.C0259-008112020-06-20
00860000688604NTrainerINNARA HEALTH, INC.A000022020-02-18
00860000688611NTrainerINNARA HEALTH, INC.A100022020-02-18
08056446900222NeMus 1EB NEURO SPAB98000660002019-05-24
08056446900239NeMus 1EB NEURO SPAB97000660002019-05-24
08056446900246Power-LAN Connection BoxEB NEURO SPAB97000700002019-05-24
08056446900260R-KEY (Dedicated Keyboard)EB NEURO SPAB97000510002019-05-24
08056446900253Power-LAN Connection Box USBEB NEURO SPAB97000701002019-04-10
08056446900369NeMus 2EB NEURO SPAB98000660102019-04-10
08056446900376NeMus 2EB NEURO SPAB97000660102019-04-10
B184A000020NTrainerINNARA HEALTH, INC.A000022017-01-17
B184A100020NTrainerINNARA HEALTH, INC.A100022018-12-15
B191HEARLABACA0HearLabFRYE ELECTRONICS, INC.ACA2017-02-11
04931921005439Neuropack S3NIHON KOHDEN CORPORATIONDC-960B2018-08-16
04931921005477Neuropack S3NIHON KOHDEN CORPORATIONJB-910B2018-08-16
04931921005484Neuropack S3NIHON KOHDEN CORPORATIONJB-962B2018-08-16
04931921005491Neuropack S3NIHON KOHDEN CORPORATIONJB-964B2018-08-16
04931921005545Neuropack S3NIHON KOHDEN CORPORATIONRY-960B2018-08-16
04931921005552Neuropack S3NIHON KOHDEN CORPORATIONSC-900B2018-08-16
04931921005736NANIHON KOHDEN CORPORATIONDI-960B2018-08-16
04931921005743NANIHON KOHDEN CORPORATIONDI-961B2018-08-16
04931921005750NANIHON KOHDEN CORPORATIONKH-960A2018-08-16
04931921006429Neuropack S3NIHON KOHDEN CORPORATIONQS-010BK2018-08-16
04931921007327Neuropack S3NIHON KOHDEN CORPORATIONYZ-004A42018-08-16
04931921100707NANIHON KOHDEN CORPORATIONLS-102J2016-09-05
04931921102169Neuropack X1NIHON KOHDEN CORPORATIONDC-230BA2016-09-05
04931921102183Neuropack S1NIHON KOHDEN CORPORATIONDC-940BA2016-09-05
04931921102930NANIHON KOHDEN CORPORATIONJB-206B2016-09-05
04931921102947NANIHON KOHDEN CORPORATIONJB-212B2016-09-05
04931921103494NANIHON KOHDEN CORPORATIONMS-230B2016-09-05
04931921104002NANIHON KOHDEN CORPORATIONPV-230B2016-09-05
04931921104828NANIHON KOHDEN CORPORATIONQP-946BK2016-09-05
04931921104835NANIHON KOHDEN CORPORATIONQP-947BK2016-09-05
04931921104842NANIHON KOHDEN CORPORATIONQP-948BK2016-09-05
04931921105313NANIHON KOHDEN CORPORATIONSEN-4100A2016-09-05
04931921105597NANIHON KOHDEN CORPORATIONVD-403B2016-09-05