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KRE — Analyzer, Pacemaker Generator Function, Indirect Class II

FDA Device Classification

Classification Details

Product Code
KRE
Device Class
Class II
Regulation Number
870.3640
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K110693medtronicPACEART OPTIMA SYSTEM SOFTWAREJune 8, 2011
K072950cygnusCYGNUS 12 LEAD ECG MODULEAugust 22, 2008
K032926medtronic vascularEKG SPEAKSOctober 15, 2003
K922742biotronik, gmbh andHPM 40 HEART PACEMAKER MONITORMarch 18, 1993
K915632paceartPACEART CPTS-86/12April 14, 1992
K895535micromedicalPACEVIEWMarch 19, 1990
K870909paceartPACEMAKER FUNCTION ANALYZERApril 27, 1987
K833647pacesetter systemsPACEMAKER SYS ANALYZER #384December 16, 1983
K832959siemens elemaPACEMAKER SYS. ANALYZER 378November 14, 1983
K803286instromedixCARDIOMEMOMarch 17, 1981
K800696instromedixELECTRONIC PACEMAKER WAVEFORM ANALYZERAugust 14, 1980
K801022powers medical systmesULTRA-CHEK PACEMAKER MONITORJune 17, 1980
K800782bibPACE-PULSE/COMPUTRACMay 28, 1980