FDA.reportPublic FDA data

Emsere, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100829093010082909Emsere, Inc.1Y2026-01-01627 Highway 74 South Suite 220 Peachtree City GA US 30269

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1739571586316712K983945CORTEX DERMASCAN C ULTRASONIC SYSTEMIYO1999-03-17
1739572031304645K973403CARDIOSMART STLOS1998-03-12
1739572037405614K915436BLADDERSCAN BVI 2500IYO1992-03-03
1739571460592164K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITORDXN1991-11-06
1739571848716111K213436Clarius Ultrasound ScannerIYN2021-11-15
1739571530090045K210654EnCor Breast Biopsy Probe with Rinse TubeKNW2021-03-31
1739571212224493K202456M5 RecorderDSH2020-12-29
1739571059478956K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXN2020-06-18
1739571912938947K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14GKNW2019-11-07
1739571395296257K192107Clarius Ultrasound ScannerIYN2019-08-29
1739571683724825K183072EndoFLIP SystemFFX2019-02-15
1739572035072186K182030Faros MobileMLO2018-11-08
1739571670311739K173895Tel-O-GraphDXN2019-05-16
1739571312757685K161536EasyOne Air SpirometerBZG2017-01-05
1739571663987573K142596Infusomat Space Volumetric Infusion PumpFRN2015-06-18
1739571111665677K122384MINISPIRBZG2012-10-04
1739571320414429K122073ELI 280 ELECTROCARDIOGRAPHDPS2012-08-02
1739571927954639K113185MODEL HBP-1300DXN2012-01-27
1739571667000516K112177SOFIA ANALYZER AND INFLUENZA A+B FIAPSZ2011-10-24
1739571790400118K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)DXN2011-12-16
1739571660037159K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITORDXN2011-02-04
1739571742036668K103530SPIRODOCBZG2011-11-21
1739571906633614K101403ELI 250 ELECTROCARDIOGRAPHDPS2010-07-02
1739572047242554K101275MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).DXN2010-05-28
1739571817264709K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPS2010-06-18
1739571832327856K100127ELI 230 ELECTROCARDIOGRAPHDPS2010-04-16
1739571219859581K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMMEA2009-11-04
1739571017935352K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRN2009-07-01
1739571052391956K082766MODIFICATION TO MINISPIR, SPIROLAB IIIBZG2008-12-17
1739571013839005K082357MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).DXN2008-10-29
1739571095111901K080954T34L SYRINGE DRIVERFRN2008-05-16
1739571085234515K070750247 BP DEVICEDXN2007-05-02
1739571880653185K062700INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRN2006-10-26
1739571202609523K062699PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMFRN2006-10-26
1739571235682552K051730MATRIX HOLTER SYSTEM, MODEL M12MLO2005-09-26
1739571488544593K050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERSFRN2005-11-23
1739571143168321K042696BODYGUARD INFUSION PUMP SYSTEMFRN2005-03-11
1739572068135150K041313STABIL-O-GRAPHDXN2004-06-18
1739571102398203K032305OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XLDXN2004-02-11
1739571403973705K023055BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200DXN2002-10-22
1739571995296239K021373H12+HOLTER RECORDERMWJ2002-06-27
1739571099957115
1739571422012454
1739571760890724
1739571911891264
1739571935449257

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN122020-06-18
FRN72015-06-18
BZG42017-01-05
DPS42012-08-02
IYN22021-11-15
KNW22021-03-31
MLO22018-11-08
IYO21999-03-17
DSH12020-12-29
FFX12019-02-15
PSZ12011-10-24
MEA12009-11-04
MWJ12002-06-27
LOS11998-03-12