FDA.reportPublic FDA data

Stephen Gorski

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041489973004148997Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30041497743004149774Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30048388363004838836Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30052850783005285078Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30128669283012866928Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30164500673016450067Stephen Gorski1N2026-01-01S65w35739 Piper Rd Eagle WI US 53119
30065511783006551178Stephen Gorski1N2020-04-25S65W35739 Piper Rd Eagle WI US 53119
30076678853007667885Stephen Gorski1N2020-04-25S65W35739 Piper Rd Eagle WI US 53119

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
229881503246439K243765LuMon(TM) SystemQEB2025-08-07
229881084692052K232516Sentec Digital Monitoring System (SDMS) tCOM+LKD2024-05-17
218231118735348K200909Hemo Control (optional Add Pack Hemo Control DM)GKR2020-06-12
247471146390208K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareDXN2018-06-21
218231604349251K172173DiaSpect Tm, DiaSpect Tm CuvettesGKR2018-04-06
229881738851328K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNetLKD2015-12-17
247471399313085K131916BPROSOFT CASP PC SOFTWAREDXN2014-03-11
247471200288721K131788HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWAREDXN2014-03-04
218231519088570K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE WGKR2011-03-04
229881433048196K101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLELKD2010-12-03
247471697834140K101002A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200DXN2010-06-08
247471457217189K072593A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWAREDXN2007-11-15
2948001240674128K072136ULTRASONIC NEBULISER MODEL 2010CAF2008-07-15
980731811204227K072136ULTRASONIC NEBULISER MODEL 2010CAF2008-07-15
229881913205117K071672SENTEC DIGITAL MONITORING SYSTEMDQA2007-09-12
247471487717778K060315HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEMDXN2006-04-07
247471620946035K051546BPCALIBRATOR MC3000/MC3100DXN2005-06-24
229881689616207K041548SENTEC DIGITAL MONITOR MODEL #SDMLKD2004-08-09
218231545223590K031898EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEMGKR2003-09-24
3169391364393653K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESCBK2002-12-20
218231814356522BK200520
218231974286667BK120052
218231357822313BK110036
980731464834770
1993061034185118
625771170684270
2948001240964043
218231248693283
218231392164781
2948001434361023
2948001527148397
1993061657579436
2948001711199488
2948001959745240

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN72018-06-21
LKD42024-05-17
GKR42020-06-12
CAF22008-07-15
QEB12025-08-07
DQA12007-09-12
CBK12002-12-20