FDA.reportPublic FDA data

SmartScreener-Plus2 Screener Launch

Primary DI
00817020020822
Brand
SmartScreener-Plus2 Screener Launch
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M812002
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
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090579000SMARTSCREENER-PLUS2Intelligent Hearing Systems2009-07-07GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020822008170200208228170200208220817020020822

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
00817020020280Capella2 OAE Start-Up Kit8-69-428002026-06-09
00817020021003B81 Bone VibratorM0144022026-06-09
00817020021010B81 Bone Vibrator CableM0144032026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaM0144052026-06-09
00817020021171Bone Vibrator Cable for AriaM0144062026-06-09
00817020020044Lilly TM-Wick Electrode CableM0139142016-09-24
00817020020068eABR Cable for USB Jr DuetM0131522016-09-24
00817020020075USB Jr DuetM0103002016-09-24
00817020020273OAE 10D ProbeM0321032016-09-24
00817020020594ER-3C Insert Earphones (300Ohms) for Solo/AriaM015302S2017-01-17
00817020020624B71 Bone VibratorM0144002016-09-24
00817020020808SmartEP SoftwareM8110002016-09-24
00817020020877SmartAudiometer SoftwareM8170002016-09-24
00817020020952USB Jr Duet Response BoxM031501D2017-01-30
00817020029993OAE 10D ProbeM032103G2018-05-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
15060753520004Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
25060753520063Tympa CloudTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
25060753520070Tympa Mobile AppTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
B43071000020GoCheck MultiScreenerGobiquity, Inc.EWO2024-09-23
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2024-03-11