Product code KRE— Cardiovascular
CARDIOMEMO
- Classification name
- Analyzer, Pacemaker Generator Function, Indirect
- Device class
- Class 2
- Regulation
- 21 CFR 870.3640
- Advisory panel
- Cardiovascular
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code KRE
FDA has cleared devices under product code KRE between 1980 and 2011, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2008
- 2003
- 1993
- 1992
- 1990
- 1987
- 1983
- 1981
- 1980
Top applicants under product code KRE
Recent clearances under product code KRE
- K110693 — PACEART OPTIMA SYSTEM SOFTWARE
- K072950 — CYGNUS 12 LEAD ECG MODULE
- K032926 — EKG SPEAKS
- K922742 — HPM 40 HEART PACEMAKER MONITOR
- K915632 — PACEART CPTS-86/12
- K895535 — PACEVIEW
- K870909 — PACEMAKER FUNCTION ANALYZER
- K833647 — PACEMAKER SYS ANALYZER #384
- K832959 — PACEMAKER SYS. ANALYZER 378
- K803286 — CARDIOMEMO
- K800696 — ELECTRONIC PACEMAKER WAVEFORM ANALYZER
- K801022 — ULTRA-CHEK PACEMAKER MONITOR
- K800782 — PACE-PULSE/COMPUTRAC
Data sourced from openFDA. This site is unofficial and independent of the FDA.