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PREVENTICE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053320833005332083Preventice Services, LLC1N2020-04-251717 N Sam Houston Pkwy W Houston TX US 77038
30098834023009883402PREVENTICE TECHNOLOGIES, INC.1N2020-04-253605 Hwy 52 N Building 003-2 ROCHESTER MN US 55901

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
656481799909122K963725MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)DXH1997-09-10
656481961748035K954495PACETRAK PLUSDXH1996-04-22
656481343622412K943995IMD PSD 410 PACEMAKER TRANSMITTERDXH1995-03-07
656481952265269K920765EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200DXH1992-07-07
656481731357025K182030Faros MobileMLO2018-11-08
656481335752079K162463Matrix Data Management SystemDXN2017-05-24
1578511956320924K151188BodyGuardian Remote Monitoring SystemDSI2015-09-17
656481958465455K151188BodyGuardian Remote Monitoring SystemDSI2015-09-17
656481972823788K143032eMotion Faros ECG MobileDXH2015-03-29
656481551403153K141813RHYTHMSTAR SYSTEMDXH2014-08-05
656481546892075K121197BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTDSI2012-08-10
1578511586034144K121197BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTDSI2012-08-10
656482044523775K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORDSI2011-06-13
656481319880299K072008BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDERDRG2007-10-03
656481141870074K043010HOLTER RECORDER H3+MWJ2005-02-25
656481544227852K031074DIGITAL AMBULATORY ECG (HOLTER) RECORDERMWJ2003-10-15
656481374223367K023418HEARTONE EVENT RECORDER AND TRANSMITTERDXH2002-11-06
656481914838502K001634CARDIOSENTRY EVENT MONITOR, MODEL 8470-01DXH2000-12-21
1578511294667616
1578511654117222

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXH82015-03-29
DSI52015-09-17
MWJ22005-02-25
MLO12018-11-08
DXN12017-05-24
DRG12007-10-03

PMN#

GUDID#

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