TA-20 Automatic Industiral Audiometer
FDA 510(k) K851015 · Teledyne Avionics Div. of Teledyne
510(k) numberK851015
Submission
- Device name
- TA-20 Automatic Industiral Audiometer
- Applicant
- Teledyne Avionics Div. of Teledyne
Charlottesville, VA, US - Received
- March 12, 1985
- Decision date
- June 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
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| 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 |
|---|---|---|
| K860262 | TA-6C - Part Number SLZ 7520ETY · Traditional | 04/23/1986SE |
| K860522 | Spirometer, Model TS-1000, Part No. SLZ7504BZG · Traditional | 03/03/1986SE |
| K855068 | Spirometer, Model TS-500 Part #SLZ7534BTY · Traditional | 02/05/1986SE |
| K855070 | Spirometer Model TS-200 SLZ 7541BZC · Traditional | 01/30/1986SE |
| K855069 | Spirometer TS-400 SLZ 7547BTY · Traditional | 01/30/1986SE |
| K854043 | Automatic Impedance Audiometer, TA-7BETY · Traditional | 12/31/1985SE |
| K850461 | Automatic Impedance Meter TA-7AETY · Traditional | 03/25/1985SE |
| K844069 | TA-201 Clinical AudiometerEWO · Traditional | 12/03/1984SE |
| K811509 | Auto-Tympanigraph (TA-5A)ETY · Traditional | 06/16/1981SE |
| K801325 | Clinical Audiometer Model TA-200EWO · Traditional | 06/30/1980SE |
Questions and answers
When was TA-20 Automatic Industiral Audiometer cleared by the FDA?
TA-20 Automatic Industiral Audiometer (K851015) received a 510(k) decision of Substantially Equivalent on June 4, 1985, 84 days after the submission was received.
What is the product code of K851015?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.