PACEART CPTS-86/12
Device Facts
| Record ID | K915632 |
|---|---|
| Device Name | PACEART CPTS-86/12 |
| Applicant | Paceart, Inc. |
| Product Code | KRE · Cardiovascular |
| Decision Date | Apr 14, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3640 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.
