CRITERION II PACING SYSTEM MONITORS
Device Facts
| Record ID | K800286 |
|---|---|
| Device Name | CRITERION II PACING SYSTEM MONITORS |
| Applicant | Dart Medical Equipment |
| Product Code | DTC · Cardiovascular |
| Decision Date | Mar 12, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
