Amplivox

Primary DI
05060488901003
Brand
Amplivox
Company
AMPLIVOX LIMITED
Model
Otowave 202
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NASTympanometer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150163000Otowave 202 Portable TympanometerAmplivox, Ltd.2015-04-23NAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488901003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488901003050604889010035060488901003

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.

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
05060488902680Amplivox Otowave 302+2023-12-22
05060488902949Amplivox modelONE2023-12-22
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
05060488902673Amplivox AMPLIVOX LIMITEDNAS2024-01-08
05060488901386AmplivoxAMPLIVOX LIMITEDNAS2017-08-08