FDA.reportPublic FDA data

Hypertec HCM LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30138966103013896610Hypertec HCM LLC1N2026-01-011570 Perry Road Plainfield IN US 46168

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2114801961900679K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI2023-10-30
2114801445425478K221282Empatica Health Monitoring PlatformDQA2022-11-20
2114801964326987K213863Everion+ SystemMSX2023-02-23
2114801989414554K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
2114801334617176K183319Triangle SystemDXH2019-05-10
2114802020965329K183078VitalConnect Platform, VitalPatch BiosensorDRG2019-03-07
2114801522014599K170723Swaive Thermometer SWT1AFLL2018-10-25
2114801547606190K150052TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring SystemNBW2015-03-26
2114802054204526K142642Vitalograph Model 6600 CompactBZG2015-06-30
2114801007481429K141542NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )DQA2014-10-02
2114801656204698K131021PULSE OXIMETERDQA2013-09-11
2114801107870926K081285FINGER PULSE OXIMETER, MODEL 9560DQA2008-06-05
2114801304438593K043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORDXN2005-03-03
2114801234264356
2114801953585252
2114801754876617

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQA42022-11-20
NBW22019-11-08
MWI12023-10-30
MSX12023-02-23
DXH12019-05-10
DRG12019-03-07
FLL12018-10-25
BZG12015-06-30
DXN12005-03-03