FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315004148
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
ICS Impulse
Device description
1085 ICS Impulse Monocular Video Frenzel US ONLY
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122550000ICS IMPULSEGn Otometrics2013-02-01GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315004148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315004148057133150041485713315004148

GMDN Terms#

Term, Definition table
TermDefinition
Visual evoked-potential graphic recorderAn electronic device designed to record an electrical potential that originates in the optical pathway of the brain in response to visual stimuli (e.g., shifting patterns of light). It is typically used as a component of a visual evoked-potential graphic recording system.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B516327270Instrumentation Difra SAInstrumentation Difra SAGWN2026-03-09
05711117244991InteracousticsInteracoustics A/SGWN2025-08-14
05711117245004InteracousticsInteracoustics A/SGWN2025-08-14
05711117245028InteracousticsInteracoustics A/SGWN2025-08-14
00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
B516325950Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326290Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326380Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
057133150107361091, ICS Dizcovery SystemNatus Medical Denmark ApSGWN2025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels Natus Medical Denmark ApSGWN2025-02-21
057133150108281091, ICS Dizcovery LCD PanelsNatus Medical Denmark ApSGWN2025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)Natus Medical Denmark ApSGWN2025-02-21
08054187380815Synapsys VHITINVENTIS SRLGWN2025-01-08
08054187380822Synapsys VHITINVENTIS SRLGWN2025-01-08
B366VN1061R00VNG 3DEclerisGWN2024-12-17
05713315007132GN Otometrics A/SNatus Medical Denmark ApSGWN2024-12-04
08054187380983VNGINVENTIS SRLGWN2024-10-01
08054187380990VNGINVENTIS SRLGWN2024-10-01
08054187381003VNGINVENTIS SRLGWN2024-10-01
08054187381010VNGINVENTIS SRLGWN2024-10-01
08054187381027VNGINVENTIS SRLGWN2024-10-01
08054187381034VNGINVENTIS SRLGWN2024-10-01
08054187381041VNGINVENTIS SRLGWN2024-10-01
08054187381058VNGINVENTIS SRLGWN2024-10-01
08054187381065VNGINVENTIS SRLGWN2024-10-01
B516308640Instrumentation Difra SAInstrumentation Difra SAGWN2024-08-19
B366VN1061VNG 3DEclerisGWN2024-05-20
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
00763000467340NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26