Fonix, Model 7000
FDA 510(k) K022510 · Frye Electronics, Inc.
510(k) numberK022510
Submission
- Device name
- Fonix, Model 7000
- Applicant
- Frye Electronics, Inc.
Tigard, OR, US - Received
- July 30, 2002
- Decision date
- August 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETW – Calibrator, Hearing Aid / Earphone And Analysis Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3310
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122028 | Aurical HitETW · Traditional | Gn Otometrics | 10/23/2012SE |
| K113831 | Primus Hearing Instrument Test UnitETW · Traditional | Auditdata A/S | 04/19/2012SE |
| K110286 | GN Otometrics Type 1053 FreefitETW · Traditional | Gn Otometrics A/S | 04/28/2011SE |
| K093006 | Fonix ,Model 8000ETW · Abbreviated | Frye Electronics, Inc. | 12/30/2009SE |
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional | Siemens Hearing Instruments, Inc. | 06/05/2007SE |
| K061104 | Speechlink 100 Type 1053ETW · Traditional | Gn Otometrics A/S | 05/03/2006SE |
| K050496 | REM440ETW · Traditional | Interacoustics A/S, Assens | 04/29/2005SE |
| K041853 | OtogramETW · Traditional | Tympany, Inc. | 09/03/2004SE |
| K012306 | Audioscan Verifit, Model VF-1ETW · Traditional | Etymonic Design, Inc. | 09/21/2001SE |
| K980377 | Fonix FP35 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 03/18/1998SE |
More from Frye Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123701 | Hearlab AcaGWJ · Traditional | 04/05/2013SE |
| K093006 | Fonix ,Model 8000ETW · Abbreviated | 12/30/2009SE |
| K980377 | Fonix FP35 Hearing Aid AnalyzerETW · Traditional | 03/18/1998SE |
| K935400 | Fonix 3500 Hearing Aid AnalyzerETW · Traditional | 01/14/1994SE |
| K913221 | Type FA10 AudiometerEWO · Traditional | 10/11/1991SE |
| 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 Fonix, Model 7000 cleared by the FDA?
Fonix, Model 7000 (K022510) received a 510(k) decision of Substantially Equivalent on August 27, 2002, 28 days after the submission was received.
What is the product code of K022510?
The FDA product code is ETW – Calibrator, Hearing Aid / Earphone And Analysis Systems, a Class II (moderate risk) device regulated under 21 CFR 874.3310.