FDA.reportPublic FDA data

Megan Olen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094909463009490946Megan Olen1N2026-01-019965 Federal Drive Colorado Springs CO US 80921

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1402711505123618K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-09-28
1402711819362590K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterOBJ2020-09-02
1402711773120415K200410Reconnaissance PV .018 OTW Digital IVUS CatheterOBJ2020-05-22
1402711638468414K193228Hamilton-G5CBK2020-05-04
1402711742659893K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-03-26
1402711037415497K181216HAMILTON-T1, HAMILTON-C1CBK2019-08-02
1402711339585341K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19
1402711706182123K161887Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-TipDQX2016-09-20
1402711269229229K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ2016-10-26
1402711880454459K153094Visions PV .035 Digital IVUS CatheterOBJ2015-12-31
1402711108053517K152829Visions PV.014P RX Digital IVUS CatheterOBJ2015-11-19
1402711519726169K150442Volcano Visions PV .018 Digital IVUS CatheterOBJ2015-09-04
1402711597140520K143701EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUMOBJ2015-08-26
1402711283603238K140980TI NASAL MASKBZD2015-02-10
1402711789416454K133681CRUX SNARE FILTER RETRIEVAL SETMMX2014-01-30
1402711657505990K131288VERRATA PRESSURE GUIDE WIREDQX2013-06-21
1402711274347077K123149SERVO-I VENTILATOR SYSTEMCBK2014-06-20
1402711320632040K122585CRUX VENA CAVA FILTER SYSTEMDTK2013-01-17
1402711018798216K121631SIMPLE T NASAL MASKBZD2012-10-05
1402711192730211K121273VISIONS PV .035 DITITAL IVUS CATHETEROBJ2012-09-10
1402711048265895K120697EAGLE EYE PLATINUM ST CATHETEROBJ2012-04-05
1402711854432645K120402CRUX VENA CAVA FILTER SYSTEMDTK2012-07-13
1402711726153292K111395PRIMEWIRE PRESTIGE PLUSDQX2011-08-01
1402711220750261K100930PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300JDQX2010-04-30
1402711115803343K092835COMFORTGEL NASAL MASKBZD2010-02-12
1402711075047446K092596EAGLE EYE PLATINUM DIGITAL IVUS CATHETEROBJ2009-12-10
1402711406831359K091572DISPOSABLE SPO2 SENSOR M1134ADQA2009-09-22
1402711384930204K080891REVOLUTION 45MHZ IVUS IMAGING CATHETEROBJ2008-05-12
1402711187635530K062605PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196TDQA2006-11-09
1402711542234415K053174LOFLO C5 CO2 SENSORCCK2006-01-12
1402711954288797K052377PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.DQA2005-11-17
1402711657833131K050995REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETEROBJ2005-06-20
1402711949982063K050762PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90MHX2005-04-22
1402711556834223K042601CAPNOSTAT 5CCK2004-11-19
1402711329734640K042306PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131ADQA2004-10-15
1402711586871128K021300MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275BDSI2002-05-08
1402711510839353
1402711679582145

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBJ122020-09-02
DQX62020-09-28
CBK42020-05-04
DQA42009-09-22
BZD32015-02-10
DTK22013-01-17
CCK22006-01-12
MMX12014-01-30
MHX12005-04-22
DSI12002-05-08