MODEL EP-2 CLINICAL STIMULATOR
Device Facts
| Record ID | K933069 |
|---|---|
| Device Name | MODEL EP-2 CLINICAL STIMULATOR |
| Applicant | Ep Medical, Inc. |
| Product Code | DTA · Cardiovascular |
| Decision Date | Oct 21, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.
