CARDIOTEST 2200
Device Facts
| Record ID | K790503 |
|---|---|
| Device Name | CARDIOTEST 2200 |
| Applicant | Cardiac Pacemakers, Inc. |
| Product Code | DTA · Cardiovascular |
| Decision Date | May 17, 1979 |
| 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.
