ELECTRONIC PACEMAKER WAVEFORM ANALYZER
Device Facts
| Record ID | K800696 |
|---|---|
| Device Name | ELECTRONIC PACEMAKER WAVEFORM ANALYZER |
| Applicant | Instromedix, Inc. |
| Product Code | KRE · Cardiovascular |
| Decision Date | Aug 14, 1980 |
| 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.
