FDA.reportPublic FDA data

DRE Medical Group Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10001227861000122786DRE Medical Group Inc.1Y2020-04-252601 Stanley Gault PKWY Louisville KY US 40223

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1868961906398520K982371MEDCO ASPIRATOR IVBTA1999-02-12
1868961694877832K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCL1998-03-30
1868961035303123K971749EASYGO ASPIRATORBTA1998-04-01
1868961523909570K932494PM PUMP ASPIRATORBTA1993-10-07
1868961684701247K152427PC ECGDPS2016-02-05
1868962067650466K151787Holter SystemDQK2016-01-27
1868961176295070K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressHGM2015-07-01
1868961004449485K143728Minhua Disposable Blood Pressure CuffDXQ2015-05-15
1868962071774316K142244CLEO PATIENT MONITORMWI2015-02-06
1868962062403586K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTFSY2014-08-07
1868961171572838K131818VITAL SIGNS MONITORDQA2013-08-30
1868961440673255K123249DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-02-08
1868961125607513K120727MFM-CMS CENTRAL MONITORING SYSTEMMHX2013-06-21
1868961141906407K113653PATIENT MONITORMHX2012-02-06
1868961004461271K113623PATIENT MONITORMHX2012-02-01
1868961382433542K110999DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMITX2011-04-26
1868961349372338K110922PATIENT MONITORMHX2011-07-20
1868961619251670K103737OMNI II PATIENT MONITORMWI2011-06-02
1868961991083294K103268OMNI EXPRESSMWI2010-11-23
1868961496052588K102835VITAL SIGNS MONITORDQA2010-12-27
1868961294705617K102140FETAL MONITORS, MODELS F2 AND F3HGM2011-01-13
1868961591044137K101539VITAL SIGNS MONITOR MODEL M3BDQA2010-11-24
1868961524003149K101052OMNI III PATIENT MONITORMWI2010-08-11
1868961849961246K091680DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMITX2009-06-19
1868961726004163K080609SWC/DWC WARMING CABINETSLHC2008-06-13
1868961615315322K080087SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULARKNG2008-03-11
1868961539855447K061102PRIMA ANAESTHESIA MACHINEBSZ2006-07-28
1868961854304611K051222AV-S ANAESTHESIA VENTILATORCBK2005-09-23
1868961162268023K002257TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100GEI2000-10-19
1868961302645029K001955AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250GEI2000-12-22
1868961019723846
1868961028897864
1868961130059534
1868961425804969
1868961558891918
1868961720129282
1868961821787062
1868961888337906
1868961910470528
1868961918124955
1868961920783272

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI42015-02-06
MHX42013-06-21
DQA32013-08-30
BTA31999-02-12
HGM22015-07-01
ITX22011-04-26
GEI22000-12-22
DPS12016-02-05
DQK12016-01-27
DXQ12015-05-15
FSY12014-08-07
IYN12013-02-08
LHC12008-06-13
KNG12008-03-11
BSZ12006-07-28
CBK12005-09-23
CCL11998-03-30