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510(k) K234095

Device
OtoNova/OtoNova Pro
Applicant
Otodynamics
510(k) number
K234095
Product code
EWO
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-21
Date received
2023-12-26
Regulation
874.1050
Classification name
Audiometer
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Daniel Budd
Address
30-38 Beaconsfield Rd. Hatfield, Hertfordshire GB AL10 8BB AL10 8BB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EWO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240430Otoport ProOtodynamics, Ltd.2024-03-15
K231545hearOAEHearx SA (Pty) , Ltd.2023-10-27
K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH2022-06-22
K191372LyraInteracoustics A/S2019-07-15
K180287GSI CortiGrason-Stadler, Inc.2018-05-11
K173567SeraInteracoustics A/S2018-02-14
K172403GSI NovusGrason-Stadler, Inc.2017-10-20
K171506EasyscreenMaico Diagnostics GmbH2017-08-29
K151025iHearTestIhear Medical, Inc.2015-12-29
K150491ER36 Series OAE Test SystemEtymotic Research, Inc.2015-03-26
K141524NEURO-AUDIOTeleemg, LLC USA2015-03-12
K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade KitOtodynamics, Ltd.2015-02-23
K133012SENTIEROPath Medical GmbH2014-06-09
K130795TITANInteracoustics A/S2013-06-20
K123624OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEMMimosa Acoustics, Inc.2013-03-28