FDA.reportPublic FDA data

510(k) K823934

Device
CARIEL F12
Applicant
ODAM
510(k) number
K823934
Product code
DYC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-16
Date received
1982-12-29
Regulation
870.2400
Classification name
Vectorcardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
REITHLER
Address
Siege Social 67160 Wissembourg France FR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023414MIDA ALGORITHM REV. BOrtivus AB2003-12-05
K896396MIDA SYSTEM, MODELS 1000/1100Medical Graphics Corp.1990-01-18
K810529DIRECT WRITING VECTORCARDIOGRAPHElmed, Inc.1981-04-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases