FDA.reportPublic FDA data

External Talk Through Microphone

Primary DI
00817020020372
Brand
External Talk Through Microphone
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M025550
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900096000INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)Artifical Hearing Systems Corp.1990-05-31EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020372008170200203728170200203720817020020372

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding microphoneA freestanding electroacoustic transducer designed to capture sound waves, usually vocal, and convert them into electrical signals that are amplified typically for various medical communication/recording or patient-assistive applications. It is not permanently attached to or integrated into another device and may operate via wireless technology. It is typically hand held, attached to clothing, or placed in a holder.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154870455
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817020021126AriaM0111602024-03-11
00817020020013EarHug PackM0154022016-09-24
00817020020358Sound Field Connector to Amp Cable (Mono Plugs)M0257012016-09-24
00817020020365Sound Field Output Cable to Amplifier (RCA Plugs)M0257042016-09-24
00817020029931Capella2 Starter Kit8-69-428002018-11-07
00817020029948EarHugs for AccuScreenM0154112016-09-24
00817020020006EarHugM0154012016-09-24
00817020020945EarHug Pack - No ElectrodesM0154042017-01-30
00817020020037Lilly TM-Wick ElectrodeM0139102016-09-24
00817020020877SmartAudiometer SoftwareM8170002016-09-24
00817020021058Bone Vibrator w/ Cable and Headband (B81)M0144042021-02-10
00817020021065DD45-300 HeadphonesM0150532021-02-10
00817020020617Bone Vibrator Cable for USBLiteM0144112016-09-24
00817020020624Bone Vibrator 300 OhmsM0144002016-09-24
00817020020631Bone Vibrator CableM0144102016-09-24
00817020020648Bone Vibrator Head BandM0144202016-09-24
00817020020655Bone Vibrator Peidatric Head BandM0144302016-09-24
00817020020808SmartEP SoftwareM8110002016-09-24
00817020020815SmartEP-ASSR SoftwareM8110072016-09-24
00817020020822SmartScreener-Plus2 Screener LaunchM8120022016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
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05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07