Product code KRE
- Device name
- Analyzer, Pacemaker Generator Function, Indirect
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3640
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110693 | PACEART OPTIMA SYSTEM SOFTWARE | Medtronic, Inc. | 2011-06-08 |
| K072950 | CYGNUS 12 LEAD ECG MODULE | Cygnus, LLC | 2008-08-22 |
| K032926 | EKG SPEAKS | Medtronic Vascular | 2003-10-15 |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Biotronik, GmbH & Co. | 1993-03-18 |
| K915632 | PACEART CPTS-86/12 | Paceart, Inc. | 1992-04-14 |
| K895535 | PACEVIEW | Micromedical | 1990-03-19 |
| K870909 | PACEMAKER FUNCTION ANALYZER | Paceart, Inc. | 1987-04-27 |
| K833647 | PACEMAKER SYS ANALYZER #384 | Pacesetter Systems | 1983-12-16 |
| K832959 | PACEMAKER SYS. ANALYZER 378 | Siemens Elema AB | 1983-11-14 |
| K803286 | CARDIOMEMO | Instromedix, Inc. | 1981-03-17 |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Instromedix, Inc. | 1980-08-14 |
| K801022 | ULTRA-CHEK PACEMAKER MONITOR | Powers Medical Systmes | 1980-06-17 |
| K800782 | PACE-PULSE/COMPUTRAC | Bib, Inc. | 1980-05-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00613994546180 | PACEART® SYSTEM ECG MODULE | MEDTRONIC, INC. | 2019-10-25 |
| 00763000083342 | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | 2018-07-02 |
| 00643169956803 | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | 2017-08-06 |
| 00643169956810 | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | 2017-07-28 |
| 00643169876927 | Paceart Optima™ System 1.6 with Analytics | MEDTRONIC, INC. | 2017-01-16 |
| 00643169707351 | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | 2016-05-07 |
| 00613994533364 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533241 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533333 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533302 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533272 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994371751 | NA | MEDTRONIC, INC. | 2016-04-01 |
| 00643169357730 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00643169552296 | PACEART OPTIMA™ System | MEDTRONIC, INC. | 2016-04-01 |
| 00643169463523 | PACEART OPTIMA™ System | MEDTRONIC, INC. | 2016-04-01 |
| 00643169411296 | PACEART OPTIMA™ System | MEDTRONIC, INC. | 2016-04-01 |
| 00643169345058 | PACEART OPTIMA™ System | MEDTRONIC, INC. | 2016-04-01 |
| 00613994845801 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533340 | PACEART® SYSTEM GET CONNECTED III, CardioVoice® TTM Assistant Software | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533319 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533296 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |
| 00613994533265 | PACEART® SYSTEM GET CONNECTED III | MEDTRONIC, INC. | 2016-04-01 |