ULTRA SOFTWARE MODULE: MODEL 2016
Device Facts
| Record ID | K863046 |
|---|---|
| Device Name | ULTRA SOFTWARE MODULE: MODEL 2016 |
| Applicant | Cardiac Pacemakers, Inc. |
| Product Code | KRG · Cardiovascular |
| Decision Date | Dec 5, 1986 |
| 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.