KRE · Analyzer, Pacemaker Generator Function, Indirect
Cardiovascular · 21 CFR 870.3640 · Class 2
Overview
| Product Code | KRE |
|---|---|
| Device Name | Analyzer, Pacemaker Generator Function, Indirect |
| Regulation | 21 CFR 870.3640 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110693 | PACEART OPTIMA SYSTEM SOFTWARE | Medtronic, Inc. | Jun 8, 2011 | SESE |
| K072950 | CYGNUS 12 LEAD ECG MODULE | Cygnus, LLC | Aug 22, 2008 | SESE |
| K032926 | EKG SPEAKS | Medtronic Vascular | Oct 15, 2003 | SESE |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Biotronik, GmbH & Co. | Mar 18, 1993 | SESE |
| K915632 | PACEART CPTS-86/12 | Paceart, Inc. | Apr 14, 1992 | SESE |
| K895535 | PACEVIEW | Micromedical | Mar 19, 1990 | SESE |
| K870909 | PACEMAKER FUNCTION ANALYZER | Paceart, Inc. | Apr 27, 1987 | SESE |
| K833647 | PACEMAKER SYS ANALYZER #384 | Pacesetter Systems | Dec 16, 1983 | SESE |
| K832959 | PACEMAKER SYS. ANALYZER 378 | Siemens Elema AB | Nov 14, 1983 | SESE |
| K803286 | CARDIOMEMO | Instromedix, Inc. | Mar 17, 1981 | SESE |
| K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER | Instromedix, Inc. | Aug 14, 1980 | SESE |
| K801022 | ULTRA-CHEK PACEMAKER MONITOR | Powers Medical Systmes | Jun 17, 1980 | SESE |
| K800782 | PACE-PULSE/COMPUTRAC | Bib, Inc. | May 28, 1980 | SESE |
Top Applicants
- Instromedix, Inc. — 2 clearances
- Paceart, Inc. — 2 clearances
- Bib, Inc. — 1 clearance
- Biotronik, GmbH & Co. — 1 clearance
- Cygnus, LLC — 1 clearance
