GN Otometrics
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2553-2019 | Class II | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadw | August 1, 2019 |
| Z-0170-2020 | Class II | The ICS CHARTR EP 200 | May 28, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K161707 | Madsen Zodiac | September 1, 2016 |
| K151504 | ICS Impulse | November 16, 2015 |
| K143670 | ICS CHARTR EP 200 WITH VEMP | October 23, 2015 |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | February 27, 2014 |
| K122550 | ICS IMPULSE | February 1, 2013 |
| K122028 | AURICAL HIT | October 23, 2012 |
| K122067 | TYPE 1077 ACCUSCREEN | September 27, 2012 |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | April 28, 2011 |
| K092373 | ICS CHARTR EP 200 | September 3, 2009 |
| K083399 | ICS CHARTR EP 200 | February 20, 2009 |
| K081234 | GN OTOMETRICS INSERT EARPHONES | July 14, 2008 |
| K061791 | FOCUS VNG/ENG TYPE 1068 | July 11, 2006 |
| K061104 | SPEECHLINK 100 TYPE 1053 | May 3, 2006 |
| K033645 | OTOFLEX 100 TYE 1012 | March 31, 2004 |