Resound Real Ear Loudness Mapping (Relm) System
FDA 510(k) K960229 · Resound Corp.
510(k) numberK960229
Submission
- Device name
- Resound Real Ear Loudness Mapping (Relm) System
- Applicant
- Resound Corp.
Redwood City, CA, US - Received
- January 17, 1996
- Decision date
- March 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsEWO · Traditional | 03/19/1999SE |
| K974257 | Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer)ESD · Traditional | 12/12/1997SE |
| K974081 | Resound Stealth CicESD · Traditional | 12/12/1997SE |
| K971605 | Resound ED4 Personal Hearing System W/Remote Control OptionESD · Traditional | 07/03/1997SE |
| K970215 | Audallion II Hearing SystemESD · Traditional | 03/31/1997SE |
| K964557 | Resound BT4 Personal Hearing System W/Remote Control OptionESD · Traditional | 11/27/1996SE |
| K964115 | Resound CC4 Personal Hearing SystemESD · Traditional | 11/04/1996SE |
| K960684 | Hearing Aid - Air ConductionESD · Traditional | 04/10/1996SE |
| K960680 | Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-Es, Edr-Ev, & EDR-P1ESD · Traditional | 04/10/1996SE |
| K960052 | Resound Personal Hearing System BT2-ES, BT2-EV, & BT241ESD · Traditional | 03/12/1996SE |
Questions and answers
When was Resound Real Ear Loudness Mapping (Relm) System cleared by the FDA?
Resound Real Ear Loudness Mapping (Relm) System (K960229) received a 510(k) decision of Substantially Equivalent on March 7, 1996, 50 days after the submission was received.
What is the product code of K960229?
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.