CPI MODEL 2215/SEAMED MODEL 3400
Device Facts
| Record ID | K910223 |
|---|---|
| Device Name | CPI MODEL 2215/SEAMED MODEL 3400 |
| Applicant | Seamed Corp. |
| Product Code | DTC · Cardiovascular |
| Decision Date | Mar 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.
