FDA.reportPublic FDA data

CARDIOSENSE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
CARDIOSENSE, INC.5N2027-01-01400 N. Aberdeen St. Suite 1050 Chicago IL US 60642

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3532301879425059K243566CardioTag™DXR2025-07-22
3532301338774549DEN250057PCWP Analysis SoftwareSIF2026-05-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SIF12026-05-22
DXR12025-07-22

GUDID#