FDA Product Code
FDA Product Code KRE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3640
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110693 | PACEART OPTIMA SYSTEM SOFTWARE | Medtronic, Inc. | 2011-06-08 | Traditional | PDF ↗ |
| K072950 | CYGNUS 12 LEAD ECG MODULE | Cygnus, LLC | 2008-08-22 | Traditional | PDF ↗ |
| K032926 | EKG SPEAKS | Medtronic Vascular | 2003-10-15 | Special | PDF ↗ |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Biotronik, GmbH & Co. | 1993-03-18 | Traditional | PDF ↗ |
| K915632 | PACEART CPTS-86/12 | Paceart, Inc. | 1992-04-14 | Traditional | PDF ↗ |
| K895535 | PACEVIEW | Micromedical | 1990-03-19 | Traditional | PDF ↗ |
| K870909 | PACEMAKER FUNCTION ANALYZER | Paceart, Inc. | 1987-04-27 | Traditional | PDF ↗ |
| K833647 | PACEMAKER SYS ANALYZER #384 | Pacesetter Systems | 1983-12-16 | Traditional | PDF ↗ |
| K832959 | PACEMAKER SYS. ANALYZER 378 | Siemens Elema AB | 1983-11-14 | Traditional | PDF ↗ |
| K803286 | CARDIOMEMO | Instromedix, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Instromedix, Inc. | 1980-08-14 | Traditional | PDF ↗ |
| K801022 | ULTRA-CHEK PACEMAKER MONITOR | Powers Medical Systmes | 1980-06-17 | Traditional | PDF ↗ |
| K800782 | PACE-PULSE/COMPUTRAC | Bib, Inc. | 1980-05-28 | Traditional | PDF ↗ |
Product code KRE · Class II · Cardiovascular. Data: openFDA.