FDA.reportPublic FDA data

Amplivox

Primary DI
05060488902673
Brand
Amplivox
Company
AMPLIVOX LIMITED
Model
Otowave 302
Published
2024-01-08
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
NASTympanometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2
NASTympanometerEar, 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
05060488902673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488902673050604889026735060488902673

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

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
05060488901157Amplivox PC8502023-12-22
05060488901409Amplivox Otosure2023-12-22
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

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Primary DI, Brand, Company table
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