# Gn Otometrics A/S

- Location (FDA's records): Schaumburg, IL
- FDA decisions: 6 (2004–2015): 6 510(k) clearances
- Product codes: ETW (2), GWJ (2), ETY (1), GWN (1)
- Predicates its devices cite: 11 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ics Medical Corp.: 4 (https://510kreport.com/company/ics-medical)
- Madsen Electronics (Canada), Ltd.: 1 (https://510kreport.com/company/madsen-electronics-canada)
- Life-Tech Intl., Inc.: 1 (https://510kreport.com/company/life-tech-intl)
- Grason-Stadler, Inc.: 1 (https://510kreport.com/company/grason-stadler)
- Gn Otometrics: 1 (https://510kreport.com/company/gn-otometrics)
- Etymonic Design, Inc.: 1 (https://510kreport.com/company/etymonic-design)

## Firms that cite its devices most
- Gn Otometrics: 3 (https://510kreport.com/company/gn-otometrics)
- Interacoustics A/S: 1 (https://510kreport.com/company/interacoustics-a-s)
- Intelligent Hearing Systems: 1 (https://510kreport.com/company/intelligent-hearing-systems)

## Its most-cited devices
- K033645: Otoflex 100 Tye 1012 (2004), cited by 2
- K143670: Ics Chartr EP 200 with Vemp (2015), cited by 2
- K083399: Ics Chartr EP 200 (2009), cited by 1
- K061791: Focus VNG/Eng Type 1068 (2006), cited by 1
- K061104: Speechlink 100 Type 1053 (2006), cited by 1

## Recent decisions
- K143670: Ics Chartr EP 200 with Vemp (Oct 23, 2015)
- K110286: GN Otometrics Type 1053 Freefit (Apr 28, 2011)
- K083399: Ics Chartr EP 200 (Feb 20, 2009)
- K061791: Focus VNG/Eng Type 1068 (Jul 11, 2006)
- K061104: Speechlink 100 Type 1053 (May 3, 2006)
- K033645: Otoflex 100 Tye 1012 (Mar 31, 2004)

Source page: https://510kreport.com/company/gn-otometrics-a-s