Company ยท DK
Gn Otometrics A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2015 | K143670 | ICS CHARTR EP 200 WITH VEMP Gn Otometrics A/S, DK | GWJ |
| Apr 28, 2011 | K110286 | GN OTOMETRICS TYPE 1053 FREEFIT Gn Otometrics A/S | ETW |
| Feb 20, 2009 | K083399 | ICS CHARTR EP 200 Gn Otometrics A/S | GWJ |
| Jul 11, 2006 | K061791 | FOCUS VNG/ENG TYPE 1068 Gn Otometrics A/S | GWN |
| May 3, 2006 | K061104 | SPEECHLINK 100 TYPE 1053 Gn Otometrics A/S, DK | ETW |
| Mar 31, 2004 | K033645 | OTOFLEX 100 TYE 1012 Gn Otometrics A/S, DK | ETY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||