DeviceClearance

GN OTOMETRICS INSERT EARPHONES— 510(k) K081234

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K081234 for GN OTOMETRICS INSERT EARPHONES, Substantially Equivalent on 2008-07-14. Applicant: Gn Otometrics.

Clearance details

Applicant
Gn Otometrics
Product code
Code EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Schaumburg, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EWO

product code EWO
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.