Speechlink 100 Type 1053
FDA 510(k) K061104 · Gn Otometrics A/S
510(k) numberK061104
Submission
- Device name
- Speechlink 100 Type 1053
- Applicant
- Gn Otometrics A/S
Taastrup, DK - Received
- April 20, 2006
- Decision date
- May 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| K050496 | REM440ETW · Traditional | Interacoustics A/S, Assens | 04/29/2005SE |
| K041853 | OtogramETW · Traditional | Tympany, Inc. | 09/03/2004SE |
| K022510 | Fonix, Model 7000ETW · Abbreviated | Frye Electronics, Inc. | 08/27/2002SE |
| 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 |
|---|---|---|
| K143670 | Ics Chartr Ep 200 with VempGWJ · Traditional | 10/23/2015SE |
| K110286 | GN Otometrics Type 1053 FreefitETW · Traditional | 04/28/2011SE |
| K083399 | Ics Chartr Ep 200GWJ · Traditional | 02/20/2009SE |
| K061791 | Focus Vng/Eng Type 1068GWN · Traditional | 07/11/2006SE |
| K033645 | Otoflex 100 Tye 1012ETY · Traditional | 03/31/2004SE |
Questions and answers
When was Speechlink 100 Type 1053 cleared by the FDA?
Speechlink 100 Type 1053 (K061104) received a 510(k) decision of Substantially Equivalent on May 3, 2006, 13 days after the submission was received.
What is the product code of K061104?
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.