FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315003707
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
1022, EAR TIP KIT, 11MM 50PCS
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ETYTester, Auditory Impedance
EWOAudiometer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910247000ZODIAC 901 MIDDLE-EAR ANALYZERMadsen Electronics (Canada) , Ltd.1991-06-19ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315003707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315003707057133150037075713315003707

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, semi-automatedAn electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00571331500960Madsen Zodiac8-04-163218-04-163212026-06-04
05713315009587Madsen Zodiac8-04-163198-04-163192026-06-04
05713315009594Madsen Zodiac8-04-163208-04-163202026-06-04
05713315009624Madsen Zodiac8-04-163238-04-163232026-06-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00571331500960Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05713315009587Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
05713315009594Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
05713315009624Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
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
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