HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
Device Facts
| Record ID | K842364 |
|---|---|
| Device Name | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR |
| Applicant | Cardiac Pacemakers, Inc. |
| Product Code | KRG · Cardiovascular |
| Decision Date | Sep 24, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3700 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.