MPE · Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
Cardiovascular · 21 CFR 870.5550 · Class 2
Overview
| Product Code | MPE |
|---|---|
| Device Name | Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker |
| Regulation | 21 CFR 870.5550 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.
Classification Rationale
Class II. The special controls for this device are:
Special Controls
*Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Physio-Control Corp. | Sep 26, 1995 | SESE |
Top Applicants
- Physio-Control Corp. — 1 clearance
