FDA.reportPublic FDA data

INTELLIGENT HEARING SYSTEMS CORP.

Matched from indexed company URL: INTELLIGENT HEARING SYSTEMS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10527231000113738INTELLIGENT HEARING SYSTEMS CORP.1N2026-01-016860 Sw 81st St MIAMI FL US 33143

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
421411234579140K964426SMARTOAEEWO1997-02-03
421411285089180K925648SMART-SCREENER (AUDITORY)GWJ1993-05-11
421411751829249K914876OPTI-AMPGWL1992-01-10
421411337207245K904926SMART-EPGWJ1991-08-02
421411614992525K900096INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)EWO1990-05-31
421411023416726K163326SmartEPGWJ2017-09-29
421411863082053K090579SMARTSCREENER-PLUS2GWJ2009-07-07
421411471649698K073384SMART COUPLER, MODEL M015401GWJ2008-02-28
421411186861498K070608SMARTEP, MODEL M010000GWJ2007-07-18
421411866940895K063402WICK ELECTRODE, MODEL M019260GXY2006-12-11
421411119348167K061443SMART USBLITE, MODEL M011120GWJ2006-06-23
421411406500794K052060OPTI-AMP DC-POWEREDGWL2005-08-31
421411279579564K031051SMARTEP-ASSR, MODEL M811007GWJ2004-02-20
421411586010425K023859SMARTTROAEEWO2003-01-08
421411297714990
421411324376661
421411778346334
421412044739152

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWJ82017-09-29
EWO32003-01-08
GWL22005-08-31
GXY12006-12-11

PMN#

GUDID#

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