Type FA10 Audiometer
FDA 510(k) K913221 · Frye Electronics, Inc.
510(k) numberK913221
Submission
- Device name
- Type FA10 Audiometer
- Applicant
- Frye Electronics, Inc.
Tigard, OR, US - Received
- July 19, 1991
- Decision date
- October 11, 1991
- 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
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| K231545 | hearOAEEWO · Traditional | Hearx SA (Pty) , Ltd. | 10/27/2023SE |
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| 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 |
|---|---|---|
| K123701 | Hearlab AcaGWJ · Traditional | 04/05/2013SE |
| K093006 | Fonix ,Model 8000ETW · Abbreviated | 12/30/2009SE |
| K022510 | Fonix, Model 7000ETW · Abbreviated | 08/27/2002SE |
| K980377 | Fonix FP35 Hearing Aid AnalyzerETW · Traditional | 03/18/1998SE |
| K935400 | Fonix 3500 Hearing Aid AnalyzerETW · Traditional | 01/14/1994SE |
| K895383 | Type FP40 Digital Hearing Aid AnalyzerETW · Traditional | 01/22/1990SE |
| K872242 | Type 6400 Real Ear Hearing Aid AnalyzerETW · Traditional | 07/10/1987SE |
| K861571 | Type 6500 Hearing Aid AnalyzerETW · Traditional | 05/30/1986SE |
| K850918 | Type FP30 Digital Hearing Aid AnalyzerETW · Traditional | 05/29/1985SE |
| K833883 | Digital Audiometer/Hearing Aid 3100EWO · Traditional | 02/21/1984SE |
Questions and answers
When was Type FA10 Audiometer cleared by the FDA?
Type FA10 Audiometer (K913221) received a 510(k) decision of Substantially Equivalent on October 11, 1991, 84 days after the submission was received.
What is the product code of K913221?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.