FDA.reportPublic FDA data

SmartEP Software

Primary DI
00817020020808
Brand
SmartEP Software
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M811000
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response
GWFStimulator, Electrical, Evoked Response
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070608000SMARTEP, MODEL M010000Intelligent Hearing Systems2007-07-18GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020808008170200208088170200208080817020020808

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154870455
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817020021126AriaM0111602024-03-11
00817020020013EarHug PackM0154022016-09-24
00817020020358Sound Field Connector to Amp Cable (Mono Plugs)M0257012016-09-24
00817020020365Sound Field Output Cable to Amplifier (RCA Plugs)M0257042016-09-24
00817020029931Capella2 Starter Kit8-69-428002018-11-07
00817020029948EarHugs for AccuScreenM0154112016-09-24
00817020020006EarHugM0154012016-09-24
00817020020945EarHug Pack - No ElectrodesM0154042017-01-30
00817020020037Lilly TM-Wick ElectrodeM0139102016-09-24
00817020020877SmartAudiometer SoftwareM8170002016-09-24
00817020021058Bone Vibrator w/ Cable and Headband (B81)M0144042021-02-10
00817020021065DD45-300 HeadphonesM0150532021-02-10
00817020020617Bone Vibrator Cable for USBLiteM0144112016-09-24
00817020020624Bone Vibrator 300 OhmsM0144002016-09-24
00817020020631Bone Vibrator CableM0144102016-09-24
00817020020648Bone Vibrator Head BandM0144202016-09-24
00817020020655Bone Vibrator Peidatric Head BandM0144302016-09-24
00817020020815SmartEP-ASSR SoftwareM8110072016-09-24
00817020020822SmartScreener-Plus2 Screener LaunchM8120022016-09-24
00817020020839SmartScreener-Plus2 AEP ModuleM8120012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19