Analyzer, Pacemaker Generator Function, Indirect
FDA product code KRE · Class II (moderate risk) · 21 CFR 870.3640 · Cardiovascular
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110693 | Paceart Optima System SoftwareKRE · Traditional | Medtronic, Inc. | 06/08/2011SE |
| K072950 | Cygnus 12 Lead ECG ModuleKRE · Traditional | Cygnus, LLC | 08/22/2008SE |
| K032926 | EKG SpeaksKRE · Special | Medtronic Vascular | 10/15/2003SE |
| K922742 | HPM 40 Heart Pacemaker MonitorKRE · Traditional | Biotronik, GmbH & Co. | 03/18/1993SE |
| K915632 | Paceart CPTS-86/12KRE · Traditional | Paceart, Inc. | 04/14/1992SE |
| K895535 | PaceviewKRE · Traditional | Micromedical | 03/19/1990SE |
| K870909 | Pacemaker Function AnalyzerKRE · Traditional | Paceart, Inc. | 04/27/1987SE |
| K833647 | Pacemaker Sys Analyzer #384KRE · Traditional | Pacesetter Systems | 12/16/1983SE |
| K832959 | Pacemaker Sys. Analyzer 378KRE · Traditional | Siemens Elema AB | 11/14/1983SE |
| K803286 | CardiomemoKRE · Traditional | Instromedix, Inc. | 03/17/1981SE |
| K800696 | Electronic Pacemaker Waveform AnalyzerKRE · Traditional | Instromedix, Inc. | 08/14/1980SE |
| K801022 | Ultra-Chek Pacemaker MonitorKRE · Traditional | Powers Medical Systmes | 06/17/1980SE |
| K800782 | Pace-Pulse/ComputracKRE · Traditional | Bib, Inc. | 05/28/1980SE |