510(k) K143395
- Device
- Otoport 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 Kit
- Applicant
- OTODYNAMICS, LTD.
- 510(k) number
- K143395
- Product code
- EWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-23
- Date received
- 2014-11-26
- 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
- Julian Rutherford
- Address
- 30-38 Beaconsfield Rd. Hatfield, Herts GB AL10 8BB AL10 8BB
FDA Registration Numbers#
- 3013557562
- 3008717264
- 3020796592
- 3011310592
- 3004052117
- 3030447506
- 1052723
- 3005053770
- 3027357482
- 3029060079
- 1450042
- 3013596041
- 3003138182
- 9611864
- 3043139378
- 1316463
- 3000279201
- 3015246392
- 3014579161
- 3019918054
- 3014656175
- 3013598036
- 3005785669
- 1220135
- 3008881376
- 3031700059
- 3008386587
- 3042989733
- 3043496923
- 3010419931
- 3004046843
- 3034880867
- 3020869111
- 3007307502
- 3030896102
- 3032870
- 3012213704
- 3012302888
- 1058264
- 3008699634
- 3010608097
- 3030089857
- 3012494290
- 3008111228
- 3005581270
- 3002821232
- 3013333417
- 3005019184
- 8021990
- 3006418479
- 3010539401
- 3011359729
- 3017644066
- 3014337591
- 2011951
- 2113281
- 9612197
- 3002504821
- 9710051
- 3014343954
Source Documents#
Other 510(k) Records For Product Code EWO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024-06-21 |
| K240430 | Otoport Pro | Otodynamics, Ltd. | 2024-03-15 |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | 2023-10-27 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | 2022-06-22 |
| K191372 | Lyra | Interacoustics A/S | 2019-07-15 |
| K180287 | GSI Corti | Grason-Stadler, Inc. | 2018-05-11 |
| K173567 | Sera | Interacoustics A/S | 2018-02-14 |
| K172403 | GSI Novus | Grason-Stadler, Inc. | 2017-10-20 |
| K171506 | Easyscreen | Maico Diagnostics GmbH | 2017-08-29 |
| K151025 | iHearTest | Ihear Medical, Inc. | 2015-12-29 |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015-03-26 |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | 2015-03-12 |
| K133012 | SENTIERO | Path Medical GmbH | 2014-06-09 |
| K130795 | TITAN | Interacoustics A/S | 2013-06-20 |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | 2013-03-28 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases