KRE — Analyzer, Pacemaker Generator Function, Indirect Class II
FDA product code KRE covers "Analyzer, Pacemaker Generator Function, Indirect", a Class II medical device regulated under 21 CFR 870.3640. Submissions are reviewed by the Cardiovascular panel. At least 13 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110693 | medtronic | PACEART OPTIMA SYSTEM SOFTWARE | June 8, 2011 |
| K072950 | cygnus | CYGNUS 12 LEAD ECG MODULE | August 22, 2008 |
| K032926 | medtronic vascular | EKG SPEAKS | October 15, 2003 |
| K922742 | biotronik, gmbh and | HPM 40 HEART PACEMAKER MONITOR | March 18, 1993 |
| K915632 | paceart | PACEART CPTS-86/12 | April 14, 1992 |
| K895535 | micromedical | PACEVIEW | March 19, 1990 |
| K870909 | paceart | PACEMAKER FUNCTION ANALYZER | April 27, 1987 |
| K833647 | pacesetter systems | PACEMAKER SYS ANALYZER #384 | December 16, 1983 |
| K832959 | siemens elema | PACEMAKER SYS. ANALYZER 378 | November 14, 1983 |
| K803286 | instromedix | CARDIOMEMO | March 17, 1981 |
| K800696 | instromedix | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | August 14, 1980 |
| K801022 | powers medical systmes | ULTRA-CHEK PACEMAKER MONITOR | June 17, 1980 |
| K800782 | bib | PACE-PULSE/COMPUTRAC | May 28, 1980 |