FDA.reportPublic FDA data

Otoport Pro User Manual - English

Primary DI
05060396173516
Brand
Otoport Pro User Manual - English
Company
OTODYNAMICS LIMITED
Model
MANABR6
Device description
Instructions For Use (User Manual) for Otoport Pro, handheld OAE & ABR instrument
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240430000Otoport ProOtodynamics, Ltd.2024-03-15EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060396173516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060396173516050603961735165060396173516

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-659-7776info@otodynamics.com

Regulatory Flags#

DUNS number
235908050
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060396171130Crib/bassinet device holster for OtoNovaNOVA-CRIB2024-08-20
05060396171512Tablet Computer for OtoNova Pro NOVA-TABLET2024-08-20
05060396171529OtoNova ChargerNOVA-CHG2024-08-20
05060396171536OtoNova Wireless Charging PadNOVA-CHG-PAD2024-08-20
05060396172243XPD Ear ProbePR-XPD2024-08-20
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProNPRO-TEC2024-08-20
05060396172809OtoNova Battery Assembly Service KitON-BATT-KIT2024-08-20
05060396173011OtoNova Pro OAE+AABR instrumentOTONOVAPRO2024-08-20
05060396173042OtoNova Pro Main PCB Service KitON2-MAIN2024-08-20
05060396173059OtoNova Pro Charger PCB Service KitON2-CHG-KIT2024-08-20
05060396173080OtoNova Pro Case Service KitON2-CASE-KIT2024-08-20
05060396173103OtoNova Pro Screener TENPRO-SCR-T2024-08-20
05060396173110OtoNova Pro Screener DPNPRO-SCR-D2024-08-20
05060396173127OtoNova Pro Screener AABRNPRO-SCR-A2024-08-20
05060396173134OtoNova Pro Screener DP+TENPRO-SCR-DT2024-08-20
05060396173141OtoNova Pro Screener TE+AABRNPRO-SCR-TA2024-08-20
05060396173158OtoNova Pro Screener DP+AABRNPRO-SCR-DA2024-08-20
05060396173165OtoNova Pro Screener DP+TE+AABRNPRO-SCR-DTA2024-08-20
05060396173172OtoNova Pro Clinical+TE+AABRNPRO-CLN-DTA2024-08-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05711117244557InteracousticsInteracoustics A/SEWO2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
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04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
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04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
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057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
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