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Interacoustics A/S

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K200529OrionAugust 12, 2020
K200534VisualEyesAugust 12, 2020
K192652TRVMay 27, 2020
K191372LyraJuly 15, 2019
K173567SeraFebruary 14, 2018
K163149VisualEyesApril 26, 2017
K162037Eclipse with VEMPMarch 23, 2017
K152112VisualEyesDecember 29, 2015
K151616AT235July 15, 2015
K131681EYESEECAM VHITSeptember 6, 2013
K130795TITANJune 20, 2013
K121847TITANNovember 29, 2012
K103760TITANMay 5, 2011
K102364NYDIAG 200December 23, 2010
K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULEJuly 22, 2009
K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEApril 9, 2009
K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEMFebruary 5, 2008
K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)June 29, 2007
K060883PILOT TEST OR DETECTIVE AUDIOMETERSJune 23, 2006
K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.December 23, 2005