Gn Otometrics A/S: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Gn Otometrics A/S” (first 2004, latest 2015), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 91 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 303 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 2 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
| GWN | Nystagmograph | 1 | 1 |
Review panels
- Ear, Nose and Throat (3)
- Neurology (3)
Most recent Gn Otometrics A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143670 | ICS CHARTR EP 200 WITH VEMP | GWJ | 2015-10-23 | 303 |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | ETW | 2011-04-28 | 87 |
| K083399 | ICS CHARTR EP 200 | GWJ | 2009-02-20 | 95 |
| K061791 | FOCUS VNG/ENG TYPE 1068 | GWN | 2006-07-11 | 15 |
| K061104 | SPEECHLINK 100 TYPE 1053 | ETW | 2006-05-03 | 13 |
| K033645 | OTOFLEX 100 TYE 1012 | ETY | 2004-03-31 | 132 |
Recalls
openFDA lists no recalls under a recalling firm named Gn Otometrics A/S.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gn Otometrics A/S?
FDA lists 6 510(k) clearances under the applicant name “Gn Otometrics A/S” (first 2004, latest 2015), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gn Otometrics A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gn Otometrics A/S is 91 days.
Which FDA product codes appear under Gn Otometrics A/S?
The most frequent FDA product codes under this applicant name are ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 2); GWJ (Stimulator, Auditory, Evoked Response, 2); ETY (Tester, Auditory Impedance, 1).
Next steps
- See all 6 Gn Otometrics A/S clearances with predicates and recalls
- Run predicate analysis for product code ETW, Gn Otometrics A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.