Medical Device Manufacturer · US , Minnesota , MN

Interacoustics A/S

17 submissions · 17 cleared · Since 2006
17
Total
17
Cleared
0
Denied

Interacoustics A/S — FDA 510(k) Submissions

Interacoustics A/S has submitted 17 FDA 510(k) premarket notifications since 2006, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nystagmograph, Audiometer, Stimulator, Auditory, Evoked Response, Apparatus, Vestibular Analysis, Tester, Auditory Impedance . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Orion
K200529 · LXV Apparatus, Vestibular... · Ear, Nose, Throat
Aug 2020 163d
VisualEyes
K200534 · GWN Nystagmograph · Ear, Nose, Throat
Aug 2020 163d
TRV
K192652 · LXV Apparatus, Vestibular... · Ear, Nose, Throat
May 2020 246d
Lyra
K191372 · EWO Audiometer · Ear, Nose, Throat
Jul 2019 54d
Sera
K173567 · EWO Audiometer · Ear, Nose, Throat
Feb 2018 86d
VisualEyes
K163149 · GWN Nystagmograph · Neurology
Apr 2017 168d
Eclipse with VEMP
K162037 · GWJ Stimulator, Auditory,... · Neurology
Mar 2017 244d
VisualEyes
K152112 · GWN Nystagmograph · Neurology
Dec 2015 153d
AT235
K151616 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Jul 2015 30d
EYESEECAM VHIT
K131681 · GWN Nystagmograph · Neurology
Sep 2013 88d
TITAN
K130795 · EWO Audiometer · Ear, Nose, Throat
Jun 2013 90d
TITAN
K121847 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Nov 2012 157d
TITAN
K103760 · GWJ Stimulator, Auditory,... · Neurology
May 2011 133d
NYDIAG 200
K102364 · LXV Apparatus, Vestibular... · Ear, Nose, Throat
Dec 2010 125d
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · GWN Nystagmograph · Neurology
Feb 2008 175d
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696 · GWJ Stimulator, Auditory,... · Neurology
Jun 2007 108d
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · EWO Audiometer · Ear, Nose, Throat
Jun 2006 84d
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