Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gn Otometrics

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K161707 Madsen ZodiacETY2016-09-01 View
510(k) K122550 ICS IMPULSEGWN2013-02-01 View
510(k) K122028 AURICAL HITETW2012-10-23 View
510(k) K122067 TYPE 1077 ACCUSCREENGWJ2012-09-27 View
510(k) K092373 ICS CHARTR EP 200GWJ2009-09-03 View
510(k) K081234 GN OTOMETRICS INSERT EARPHONESEWO2008-07-14 View
↑