EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
Device Facts
| Record ID | K903966 |
|---|---|
| Device Name | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 |
| Applicant | Bio-Tek Instruments, Inc. |
| Product Code | DTC · Cardiovascular |
| Decision Date | Jun 19, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
