Tubephone Models ER-3A & ER-3 Insert Earphones
FDA 510(k) K930003 · Etymotic Research
510(k) numberK930003
Submission
- Device name
- Tubephone Models ER-3A & ER-3 Insert Earphones
- Applicant
- Etymotic Research
Elk Grove Village, IL, US - Received
- January 4, 1993
- Decision date
- June 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234095 | OtoNova/OtoNova ProEWO · Traditional | Otodynamics | 06/21/2024SE |
| K240430 | Otoport ProEWO · Special | Otodynamics, Ltd. | 03/15/2024SE |
| K231545 | hearOAEEWO · Traditional | Hearx SA (Pty) , Ltd. | 10/27/2023SE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional | Path Medical GmbH | 06/22/2022SE |
| K191372 | LyraEWO · Traditional | Interacoustics A/S | 07/15/2019SE |
| K180287 | GSI CortiEWO · Traditional | Grason-Stadler, Inc. | 05/11/2018SE |
| K173567 | SeraEWO · Traditional | Interacoustics A/S | 02/14/2018SE |
| K172403 | GSI NovusEWO · Traditional | Grason-Stadler, Inc. | 10/20/2017SE |
| K171506 | EasyscreenEWO · Traditional | Maico Diagnostics GmbH | 08/29/2017SE |
| K151025 | iHearTestEWO · Traditional | Ihear Medical, Inc. | 12/29/2015SE |
More from Ihear Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150491 | ER36 Series OAE Test SystemEWO · Special | 03/26/2015SE |
| K112733 | ER35 Ero-Scan Pro Hearing Test SystemEWO · Traditional | 12/16/2011SE |
| K070880 | ER35 Ero-Scan Pro Hearing Test SystemEWO · Traditional | 06/07/2007SE |
| K011114 | Etymotic Research ER-10D Oae ProbeEWO · Traditional | 07/03/2001SE |
| K010165 | Ero Scan Oae Test SystemEWO · Traditional | 03/12/2001SE |
| K980533 | Ero-Scan Otoacoustic Emissions Test Inst. (ER34)EWO · Traditional | 03/23/1998SE |
| K930553 | Cub Dis Otoacoustic Emissions Test InstrumentEWO · Traditional | 09/29/1993SE |
| K873298 | Elec-TipGXY · Traditional | 11/24/1987SE |
| K861113 | ER-7C Clinical Probe MicrophoneETW · Traditional | 04/23/1986SE |
| K843144 | K-Bass Lo Frequency Hearing AidESD · Traditional | 09/07/1984SE |
Questions and answers
When was Tubephone Models ER-3A & ER-3 Insert Earphones cleared by the FDA?
Tubephone Models ER-3A & ER-3 Insert Earphones (K930003) received a 510(k) decision of Substantially Equivalent on June 18, 1993, 165 days after the submission was received.
What is the product code of K930003?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.