Panels › Cardiovascular › Product code KRE · Class 2
Analyzer, Pacemaker Generator Function, Indirect
Regulation 870.3640
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KRE
| Company | 510(k)s | Recalls |
|---|---|---|
| Instromedix, Inc. | 2 | 0 |
| Paceart, Inc. | 2 | 0 |
| Bib, Inc. | 1 | 0 |
| Biotronik, GmbH & Co. | 1 | 0 |
| Cygnus, LLC | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Medtronic Vascular | 1 | 0 |
| Micromedical | 1 | 0 |
| Pacesetter Systems | 1 | 0 |
| Powers Medical Systmes | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 2011 | K110693 | PACEART OPTIMA SYSTEM SOFTWARE Medtronic, Inc. | KRE |
| Aug 22, 2008 | K072950 | CYGNUS 12 LEAD ECG MODULE Cygnus, LLC | KRE |
| Oct 15, 2003 | K032926 | EKG SPEAKS Medtronic Vascular | KRE |
| Mar 18, 1993 | K922742 | HPM 40 HEART PACEMAKER MONITOR Biotronik, GmbH & Co. | KRE |
| Apr 14, 1992 | K915632 | PACEART CPTS-86/12 Paceart, Inc. | KRE |
| Mar 19, 1990 | K895535 | PACEVIEW Micromedical | KRE |
| Apr 27, 1987 | K870909 | PACEMAKER FUNCTION ANALYZER Paceart, Inc. | KRE |
| Dec 16, 1983 | K833647 | PACEMAKER SYS ANALYZER #384 Pacesetter Systems | KRE |
| Nov 14, 1983 | K832959 | PACEMAKER SYS. ANALYZER 378 Siemens Elema AB | KRE |
| Mar 17, 1981 | K803286 | CARDIOMEMO Instromedix, Inc. | KRE |
| Aug 14, 1980 | K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER Instromedix, Inc. | KRE |
| Jun 17, 1980 | K801022 | ULTRA-CHEK PACEMAKER MONITOR Powers Medical Systmes | KRE |
| May 28, 1980 | K800782 | PACE-PULSE/COMPUTRAC Bib, Inc. | KRE |
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