Unity 2 Hia & Probe ( for Use with Unity 2)
FDA 510(k) K071462 · Siemens Hearing Instruments, Inc.
510(k) numberK071462
Submission
- Device name
- Unity 2 Hia & Probe ( for Use with Unity 2)
- Applicant
- Siemens Hearing Instruments, Inc.
Piscataway, NJ, US - Received
- May 25, 2007
- Decision date
- June 5, 2007
- 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
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| K093006 | Fonix ,Model 8000ETW · Abbreviated | Frye Electronics, Inc. | 12/30/2009SE |
| 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 |
| K980377 | Fonix FP35 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 03/18/1998SE |
More from Frye Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K951896 | Intelivenience Programmable Full Dynamic Range Compression Behind the Ear Hearing…ESD · Traditional | 05/30/1995SE |
Questions and answers
When was Unity 2 Hia & Probe ( for Use with Unity 2) cleared by the FDA?
Unity 2 Hia & Probe ( for Use with Unity 2) (K071462) received a 510(k) decision of Substantially Equivalent on June 5, 2007, 11 days after the submission was received.
What is the product code of K071462?
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.