Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity Sopftware Suite
FDA 510(k) K952098 · Siemens Hearing Instruments, Inc.
510(k) numberK952098
Submission
- Device name
- Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity Sopftware Suite
- Applicant
- Siemens Hearing Instruments, Inc.
Piscataway, NJ, US - Received
- May 4, 1995
- Decision date
- May 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional | 06/05/2007SE |
| K011364 | Custom Tci (Tinnitus Control Instrument)KLW · Traditional | 06/07/2001SE |
| K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination)KLW · Traditional | 06/01/2001SE |
| K003559 | Tci (Tinnitus Control Instrument)KLW · Traditional | 04/26/2001SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | 04/24/2001SE |
| K972998 | PrismaESD · Traditional | 09/05/1997SE |
| K962170 | Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PPESD · Traditional | 07/25/1996SE |
| K952940 | Personal Programmer 2000ESD · Traditional | 07/26/1995SE |
| K951828 | Full Dynamic Range Compression Behind the Ear Hearing InstrumentESD · Traditional | 06/30/1995SE |
| K952263 | Programmable Two Memory, Single Band Behind the Ear Hearing InstrumentESD · Traditional | 06/05/1995SE |
Questions and answers
When was Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity Sopftware Suite cleared by the FDA?
Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity Sopftware Suite (K952098) received a 510(k) decision of Substantially Equivalent on May 25, 1995, 21 days after the submission was received.
What is the product code of K952098?
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.