FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315005565
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
1096, PC, DIAGNOSTIC, CLASS, US
Catalog number
8-04-16032
Published
2018-03-02
Public version status
Update
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
K161707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161707000Madsen ZodiacGn Otometrics2016-09-01ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315005565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315005565057133150055655713315005565

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
306633756
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315009426Madsen Zodiac8-04-163038-04-163032026-06-03
05713315009433Madsen Zodiac8-04-163048-04-163042026-06-03
05713315009457Madsen Zodiac8-04-163068-04-163062026-06-03
05713315009471Madsen Zodiac8-04-163088-04-163082026-06-03
05713315009488Madsen Zodiac8-04-163098-04-163092026-06-03
05713315009501Madsen Zodiac8-04-163118-04-163112026-06-03
05713315009518Madsen Zodiac8-04-163128-04-163122026-06-03
05713315009525Madsen Zodiac8-04-163138-04-163132026-06-03
05713315009532Madsen Zodiac8-04-163148-04-163142026-06-03
05713315009556Madsen Zodiac8-04-163168-04-163162026-06-03
05713315009570Madsen Zodiac8-04-163188-04-163182026-06-03
05713315009402Madsen Zodiac8-04-163012026-06-02
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315002649GN Otometrics A/S"Disposable Electrode 24"" Wired Qty 10"2016-09-26
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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