IMEDRIX DIAGNOSTICS CORPORATION

Matched from indexed company URL: IMEDRIX INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306390993030639099IMEDRIX DIAGNOSTICS CORPORATION1N2026-01-016 Windy Top Lane Chester NJ US 07930
30165934533016593453IMEDRIX INC1N2020-04-251525 McCarthy Blvd Suite 1059 Milpitas CA US 95035

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2384191216390282K191692KardioScreenDPS2020-01-10
3261381781576938K191692KardioScreenDPS2020-01-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS22020-01-10

PMN#

GUDID#

KARDIOSCREEN - KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis.Senior Virtual HealthDevice DetailsKS-A00104,KS-A00110,KS-A00111,KS-A00112,KS-A00115,KS-A00117,KS-A00122,KS-A00131,KS-A00133,KS-A00136,KS-A00138,KS-A00139,KS-A00142,KS-A00145,KS-A00148,KS-A00149,KS-A00150KS Converter DetailsKS-CN-A00104,KS-CN-A00110,KS-CN-A00111,KS-CN-A00112,KS-CN-A00115,KS-CN-A00117,KS-CN-A00122,KS-CN-A00131,KS-CN-A00133,KS-CN-A00136,KS-CN-A00138,KS-CN-A00139,KS-CN-A00142,KS-CN-A00145,KS-CS-A00148,KS-CN-A00149,KS-CN-A00150Cable DetailsCMP220113-003 202201130002,CMP220113-003 202201130017,CMP220110-004 202201140008,CMP220110-004 202201140015,CMP220113-003 202201130026,CMP220113-003 202201130009,CMP220110-004 202201140023,CMP220113-003 202201130021,CMP220113-003 202201130022,CMP220113-003 202201130004,CMP220110-004 202201140018,CMP220113-003 202201130018,CMP220113-003 202201130010,CMP220110-004 202201140033,CMP220110-004 202201140027,CMP220113-003 202201130024,CMP220113-003 202201130001

IMEDRIX INC.

2024-01-11