FDA.reportPublic FDA data

GoCheck Audiometric Headphone Assembly

Primary DI
B43061000060
Brand
GoCheck Audiometric Headphone Assembly
Company
Gobiquity, Inc.
Model
Sennheiser HD280 Pro
Device description
Audiometric Headphone Final Assembly
Published
2024-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETTCushion, Earphone (For Audiometric Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B43061000060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometerAn electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.

Contacts#

Phone, Email table
PhoneEmail
866-633-9243support@gocheckkids.com

Regulatory Flags#

DUNS number
035145840
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B43061000100GoCheck Audiometric Headphone AssemblySennheiser HD280 Pro for i152026-06-02
B430GCKIOS5430GoCheck KidsiPhone 5.4.32023-06-15
B43050085600GoCheck KidsVision Mobile Application Version 5.6.02025-10-22
B430GCKNOK44290LGoCheck KidsNokia 4.4.292017-02-11
B430GCKNOK4630GoCheck KidsNokia 4.6.3GCKNOK4632017-06-06
B43071000030GoCheck MultiScreeneri15 Pro2025-11-19
B43050085700GoCheck KidsVision Mobile Application Version 5.7.02026-01-09
B43056000011110GoCheckHearing Mobile App V1.1.12026-01-09
B43050085610GoCheck KidsVision Mobile Application Version 5.6.12025-11-04
B43056000011100GoCheckHearing Mobile App V1.1.02025-12-02
B43050085500GoCheck KidsVision Mobile Application Version 5.5.02025-03-20
B43056000011000GoCheckHearing Mobile App V1.0.02024-09-23
B43071000020GoCheck MultiScreeneri7 Plus2024-09-23
B43050085440GoCheck KidsMobile Application Version 5.4.42024-07-26
B43071000010GoCheck KidsV5 i15 PFC2024-07-26
B43060030010GoCheck KidsV5 i7 PFC2023-07-06
B430GCKNOK44360GoCheck KidsNokia 4.4.362016-12-30
B430GCKNOK44600GoCheck KidsNokia 4.4.60GCKNOK2017-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.ETT2026-06-02
04260223146589Ear Tip ET-LT40G Pack/100 pcs.PATH medical GmbHETT2023-11-14
10840162500317Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500324Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500331Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500348Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500355Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500362Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500379Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500386Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500393Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500409Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500416Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500423Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500430Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500447Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500775Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500782Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500799Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500805Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500812Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500829Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500836Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500843Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500850Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500867Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500874Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500164Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500171Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500188Grason & Associates, LLCGrason & Associates LLCETT2022-11-10