FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315000119
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
Accessory box
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122028000AURICAL HITGn Otometrics2012-10-23ETW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315000119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315000119057133150001195713315000119

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid tester, electricalAn assembly of electronic reference devices intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid, or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distortion analyser, a chart recorder, and a hearing aid test box. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

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
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19
057133150000581052 OTOsuite8-49-758008-49-758002026-06-22
057133150007511066 OTOsuite8-49-880008-49-880002026-06-22
057133150007681052 OTOsuite8-49-906008-49-906002026-06-22
05713315009051Natus8-62-453008-62-453002021-04-12
05713315008689Natus1053 Freefit Charger8-62-393032021-01-04
05713315005848GN Otometrics A/SProbe Tube Holder mk28-62-608002019-04-24
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle8-62-415032016-09-19
05713315001055GN Otometrics A/SFreeFit REM probe8-69-392032016-09-19
05713315001192GN Otometrics A/SPMM RECD Probe Short8-69-392072016-09-19
05713315001208GN Otometrics A/SPMM RECD Probe Long8-69-392082016-09-19
05713315001215GN Otometrics A/SPMM RECD Probe Bin Long8-69-392092016-09-19
05713315001222GN Otometrics A/SPMM RECD Probe Bin Short8-69-392102016-09-19
05713315001246GN Otometrics A/SRECD Eartip Kit1-25-139042016-09-19
05713315001253GN Otometrics A/SRECD Fitting Kit8-62-490002016-09-19
05713315001277GN Otometrics A/SSoundHub 1008-62-423002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004006Unity 3Auditdata A/SETW2024-10-21
05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
05711117228458Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15
05711117198218InteracousticsInteracoustics A/SETW2019-11-26
B161VA3000Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
B161VA3003Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
05713315005848GN Otometrics A/SNatus Medical Denmark ApSETW2019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSETW2019-03-18
05713315005701GN Otometrics A/SNatus Medical Denmark ApSETW2018-11-06
05713315003301GN Otometrics A/SNatus Medical Denmark ApSETW2018-07-31
08054187380730DRUMINVENTIS SRLETW2017-08-24