FDA.reportPublic FDA data

510(k) K800696

Device
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
Applicant
INSTROMEDIX, INC.
510(k) number
K800696
Product code
KRE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-14
Date received
1980-03-28
Regulation
870.3640
Classification name
Analyzer, Pacemaker Generator Function, Indirect
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110693PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.2011-06-08
K072950CYGNUS 12 LEAD ECG MODULECygnus, LLC2008-08-22
K032926EKG SPEAKSMedtronic Vascular2003-10-15
K922742HPM 40 HEART PACEMAKER MONITORBiotronik, GmbH & Co.1993-03-18
K915632PACEART CPTS-86/12Paceart, Inc.1992-04-14
K895535PACEVIEWMicromedical1990-03-19
K870909PACEMAKER FUNCTION ANALYZERPaceart, Inc.1987-04-27
K833647PACEMAKER SYS ANALYZER #384Pacesetter Systems1983-12-16
K832959PACEMAKER SYS. ANALYZER 378Siemens Elema AB1983-11-14
K803286CARDIOMEMOInstromedix, Inc.1981-03-17
K801022ULTRA-CHEK PACEMAKER MONITORPowers Medical Systmes1980-06-17
K800782PACE-PULSE/COMPUTRACBib, Inc.1980-05-28

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