PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
Device Facts
| Record ID | K901332 |
|---|---|
| Device Name | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE |
| Applicant | Biotronik, GmbH & Co. |
| Product Code | DTC · Cardiovascular |
| Decision Date | May 9, 1990 |
| 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.
