ESORT II + 400 SERIES MONITOR
Device Facts
| Record ID | K961138 |
|---|---|
| Device Name | ESORT II + 400 SERIES MONITOR |
| Applicant | Medical Data Electronics |
| Product Code | DRO · Cardiovascular |
| Decision Date | Dec 10, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5550 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
