# Gn Otometrics

- Location (FDA's records): Naples, FL
- FDA decisions: 8 (2008–2016): 8 510(k) clearances
- Product codes: GWJ (3), GWN (2), ETW (1), EWO (1), ETY (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 9 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gn Otometrics A/S: 3 (https://510kreport.com/company/gn-otometrics-a-s)
- Micromedical Technologies, Inc.: 2 (https://510kreport.com/company/micromedical-technologies)
- Fischer-Zoth Audiologic Systems, Inc.: 2 (https://510kreport.com/company/fischer-zoth-audiologic-systems)
- Auditdata A/S: 1 (https://510kreport.com/company/auditdata-a-s)
- Ics Medical Corp.: 1 (https://510kreport.com/company/ics-medical)
- Etymotic Research: 1 (https://510kreport.com/company/etymotic-research)

## Firms that cite its devices most
- Path Medical GmbH: 2 (https://510kreport.com/company/path-medical)
- Natus Medical Denmark Aps: 1 (https://510kreport.com/company/natus-medical-denmark)
- Isent Tech & Trading Company, Ltd.: 1 (https://510kreport.com/company/isent-tech-trading)
- Otodynamics, Ltd.: 1 (https://510kreport.com/company/otodynamics)
- Inventis S.R.L.: 1 (https://510kreport.com/company/inventis)
- Gn Otometrics A/S: 1 (https://510kreport.com/company/gn-otometrics-a-s)

## Its most-cited devices
- K151504: ICS Impulse (2015), cited by 3
- K092373: Ics Chartr EP 200 (2009), cited by 2
- K122067: Type 1077 Accuscreen (2012), cited by 2
- K122550: Ics Impulse (2013), cited by 1
- K132957: Madsen Accuscreen Type 1077 (2014), cited by 1

## Recent decisions
- K161707: Madsen Zodiac (Sep 1, 2016)
- K151504: ICS Impulse (Nov 16, 2015)
- K132957: Madsen Accuscreen Type 1077 (Feb 27, 2014)
- K122550: Ics Impulse (Feb 1, 2013)
- K122028: Aurical Hit (Oct 23, 2012)
- K122067: Type 1077 Accuscreen (Sep 27, 2012)
- K092373: Ics Chartr EP 200 (Sep 3, 2009)
- K081234: GN Otometrics Insert Earphones (Jul 14, 2008)

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