FDA.reportPublic FDA data

UNIVERSAL ELECTRONICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30027363723004631140UNIVERSAL ELECTRONICS, INC.1N2020-04-25640 N. PROSPECT DR. WHITEWATER WI US 53190

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
596871918328025K9434043301 PULSE OXIMETERDQA1994-10-13
596871516519046K162282CardioChek Plus Test System, CardioChek Home Test SystemCGA2016-12-22
596871431487446K161454Propeller Sensor Model 2015-ECAF2016-11-01
596871505510552K160499Apnea Risk Evaluation System (ARES), Model 620MNR2017-04-24
596871263846511K152882Propeller SystemCAF2016-03-08
596871968629776K152482Propeller Sensor Model 2014-RCAF2016-03-04
596871487050297K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemCHH2016-12-22
596871923707101K143671Propeller Model 2014-D SensorCAF2015-06-19
596871376704679K142516Propeller SystemCAF2015-05-15
596871590286151K112514APNEA RISK EVALUATION SYSTEM (ARES)MNR2012-01-09
596871269880462K101242GENESIS DM MODEL: 6053000A1DRG2010-06-11
596871265701547K061087GENESIS OTC MONITORDRG2006-06-09
596871656042837K014099BIOSCANNER PLUSNBW2001-12-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF52016-11-01
MNR22017-04-24
DRG22010-06-11
CHH12016-12-22
CGA12016-12-22
NBW12001-12-21
DQA11994-10-13