FDA.reportPublic FDA data

EDMONDO ROARK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30247902423024790242EDMONDO ROARK1N2026-01-01624 Athens Avenue Cincinnati, Ohio 45226 Cincinnati, Ohio, 45226 Cincinnati OH US 45226

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3097611618717375K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)DXN2026-08-26
3097611732253059K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)DXN2026-08-13
3097611969544738K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)DXN2026-04-28
3097611121768672K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)DXN2025-06-26
3097611336161212K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)DXN2025-01-13
3097611424399684K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2023-08-25
3097611104232333K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-03-01
3097611346717995K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-01-05
3097611405061270K190886Non-invasive blood pressure measurement systemsDXN2019-07-29
3097611405666366K190873Infrared Ear/Forehead ThermometerFLL2019-07-26
3097611246235441K183393Digital ThermometerFLL2019-11-18
3097611368775725K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL2018-10-29
3097611542020348K181081Infrared Ear ThermometerFLL2018-10-02
3097611536139201K173024Non-invasive blood pressure measurement systemsDXN2018-08-22
3097611610381239K172989Electric Breast PumpHGX2017-12-20
3097611283257286K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXN2017-11-22
3097611909544875K163518Digital ThermometerFLL2017-09-19
3097611012899848
3097611132762775
3097611548374894
3097611578877356
3097611763642572
3097611869308123

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN122026-08-26
FLL52019-11-18
HGX12017-12-20