Cas (Computerized Analyzer System)
FDA 510(k) K896996 · Gn Danavox, Inc.
510(k) numberK896996
Submission
- Device name
- Cas (Computerized Analyzer System)
- Applicant
- Gn Danavox, Inc.
Eden Prairie, MN, US - Received
- December 11, 1989
- Decision date
- August 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K022510 | Fonix, Model 7000ETW · Abbreviated | Frye Electronics, Inc. | 08/27/2002SE |
| K012306 | Audioscan Verifit, Model VF-1ETW · Traditional | Etymonic Design, Inc. | 09/21/2001SE |
More from Etymonic Design, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971032 | Danavox Models 163/162 BteESD · Traditional | 06/17/1997SE |
| K971031 | Audallion III Hearing SystemESD · Traditional | 06/17/1997SE |
| K942331 | Danavox Model CicESD · Traditional | 11/15/1994SE |
| K924185 | DFS Genius BteESD · Traditional | 11/03/1992SE |
| K905692 | 143 Series BteESD · Traditional | 01/28/1991SE |
| K905679 | 133 Series BteESD · Traditional | 01/28/1991SE |
| K896995 | Discretion, in the Canal Hearing InstrumentESD · Traditional | 04/30/1990SE |
| K891594 | Cerumen FilterESD · Traditional | 05/10/1989SE |
| K863975 | Custom In-The-EarESD · Traditional | 11/07/1986SE |
Questions and answers
When was Cas (Computerized Analyzer System) cleared by the FDA?
Cas (Computerized Analyzer System) (K896996) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 241 days after the submission was received.
What is the product code of K896996?
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.