FDA.reportPublic FDA data

Amplivox

Primary DI
05060488902680
Brand
Amplivox
Company
AMPLIVOX LIMITED
Model
Otowave 302+
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
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171265000Otowave 302 Portable TympanometerAmplivox, Ltd.2017-07-28NAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488902680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488902680050604889026805060488902680

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
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
05060488901409Amplivox Otosure2023-12-22
05060488901645Amplivox Model 270+2023-12-22
05060488902635Amplivox Otowave 102-C2023-12-22
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
05713315009426Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009433Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009457Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009471Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009488Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009501Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009518Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009525Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009532Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009556Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009570Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009402Madsen ZodiacNatus Medical Denmark ApSETY2026-06-02
08051597160051ResonanceM.R.S. SRLETY2025-09-01
08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
05060488902635Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
05713315009396Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009907Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009914Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009389Madsen ZodiacNatus Medical Denmark ApSETY2022-12-12
05713315009464Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
00571331500946Madsen ZodiacGn Otometrics A/SETY2022-12-05