FDA.reportPublic FDA data

Salux™

Primary DI
00860007826641
Brand
Salux™
Company
Examinetics, Inc.
Model
SALUX-SW-02
Catalog number
SALUX-SW-02
Device description
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Published
2023-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007826627PreviousGS10
00860007826641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007826627008600078266278600078266270860007826627
00860007826641008600078266418600078266410860007826641

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, semi-automatedAn electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
913-748-2000clientengagement@examinetics.com

Regulatory Flags#

DUNS number
147251958
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007826634Salux™SALUX-AU-02SALUX-AU-022023-05-09
00860007826603Salux™SALUX-AU-01SALUX-AU-012022-01-27
00860007826610Salux™SALUX-HP-01SALUX-HP-012022-01-27
00860007826627Salux™SALUX-SW-01SALUX-SW-012022-01-27

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
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14