FDA.reportPublic FDA data

NA

Primary DI
B2075003070
Brand
NA
Company
BENSON MEDICAL INSTRUMENTS COMPANY
Model
CCA-100M
Catalog number
NA
Device description
AUDIOMETER
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2075003070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, automatedAn electroacoustic device designed to be used in a clinical setting 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. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. 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

Contacts#

Phone, Email table
PhoneEmail
612-827-2222TECHSUPPORT@BENSONMEDICAL.COM

Regulatory Flags#

DUNS number
957930696
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B207500326100NA500326-100500326-1002016-10-22
B207500434100NA500434-100NA2016-09-16
B2075003470NACCS-200NA2016-09-16
B2075002960NANEXTNA2016-09-16
B2075003030NACCA-200MNA2016-09-16
B2075003220NASMART TONENA2016-09-16
B2075004420Benson Medical Instruments Co.CCF200NA2017-05-01

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00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
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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
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05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
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05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14