FDA.reportPublic FDA data

Otogram

Primary DI
M737G55001
Brand
Otogram
Company
Ototronix, LLC
Model
G5500
Device description
Otogram G5500
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070118000OTOGRAM, CA3350Tympany, Inc.2007-03-07EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M737G55001PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
833067478
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M737M31101MAXUMM31102022-03-29
M737M31991MAXUMM31992022-03-29
M737M53031MAXUMM53032022-03-29
M7379860011PROCEM986-001986-0012020-12-02
M7379860021PROCEM986-002986-0022020-12-02
M7379860031PROCEM986-003986-0032020-12-02
M7379860041PROCEM986-004986-0042020-12-02
M737P97201PROCEMP97202020-12-02
M737P97301PROCEMP97302020-12-02
M737P97401PROCEMP97402020-12-02
M737G50001OtogramG50002016-09-13
M737M210L1MAXUMM210L2014-09-03
M737M210R1MAXUMM210R2014-09-03
M737M220L1MAXUMM220L2014-09-03
M737M220R1MAXUMM220R2014-09-03
M737M31001MAXUMM31002014-09-03
M737M410L1MAXUMM410L2014-09-03
M737M410R1MAXUMM410R2014-09-03
M737M420L1MAXUMM420L2014-09-03
M737M420R1MAXUMM420R2014-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
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
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
04260223147326nanoAudio DD45PATH medical GmbHEWO2025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbHEWO2025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbHEWO2025-08-05