FDA.reportPublic FDA data

510(k) K183201

Device
Hearing Healthcare Pro
Applicant
DB Diagnostic Systems, Inc.
510(k) number
K183201
Product code
ETY  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-06
Date received
2018-11-19
Regulation
874.1090
Classification name
Tester, Auditory Impedance
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Steven Levine
Address
17 Sachem Rd. Weston CT US 06883 06883

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.2017-08-02
K162210touchTympMaico Diagnostics GmbH2016-11-16
K161707Madsen ZodiacGn Otometrics2016-09-01
K151616AT235Interacoustics A/S2015-07-15
K151509GSI TympStar Pro Middle Ear AnalyzerDiagnostic Group, Dba Grason-Stadler2015-06-25
K133013INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTEInventis S.R.L.2014-01-24
K121847TITANInteracoustics A/S2012-11-29
K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS2009-04-09
K081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETERAmplivox, Ltd.2008-07-16
K070312EARCHECK ACOUSTIC REFLECTOMETERInnovia Medical, LLC2007-03-02
K033645OTOFLEX 100 TYE 1012Gn Otometrics A/S2004-03-31
K031978AMPLAID A756 SCREENING ADMITTANCE METERAmplaid2003-07-21
K022728AUDIOTRAVELLER, MODEL AA222Interacoustics A/S, Assens2002-10-11
K000097GSI 2000 MIDDLE EAR ANALYZERGrason-Stadler, Inc.2000-04-12
K994254INTERACOUSTICS AT235 IMPEDANCE AUDIOMETERInternational Distributors of Electronics For Medi2000-03-14