FDA.reportPublic FDA data

Amplivox

Primary DI
05060488901409
Brand
Amplivox
Company
AMPLIVOX LIMITED
Model
Otosure
Published
2023-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05060488901409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488901409050604889014095060488901409

GMDN Terms#

Term, Definition table
TermDefinition
Vestibulo-auditory analysis systemAn assembly of devices designed to assess the function of the auditory and vestibular systems using multiple vestibulo-auditory parameters which include audiometry (e.g., air, bone, speech), tympanometry, auditory evoked-potential (AEP) [e.g., auditory brainstem response (ABR)], otoacoustic emission (OAE), auditory steady-state response (ASSR), and vestibular evoked myogenic potential (VEMP). It includes a console which may be connected to an off-the-shelf computer, devices used for the transmission of stimuli and reception of electrical signals generated by the patient (e.g., preamplifier, audiometric ear tips, electrodes), and dedicated software. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
226599157
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488902673Amplivox Otowave 302 2024-01-08
05060488901157Amplivox PC8502023-12-22
05060488901645Amplivox Model 270+2023-12-22
05060488902635Amplivox Otowave 102-C2023-12-22
05060488902680Amplivox Otowave 302+2023-12-22
05060488902949Amplivox modelONE2023-12-22
05060488901003AmplivoxOtowave 2022016-09-24
05060488901010AmplivoxOtowave 1022016-09-24
05060488901027AmplivoxModel 2602016-09-24
05060488901034AmplivoxModel 2402016-09-24
05060488901102AmplivoxModel 2702016-09-24
05060488901164AmplivoxModel 1702016-09-24
05060488901171AmplivoxModel 1162016-10-06
05060488901386AmplivoxOtowave 3022017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07