OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
Device Facts
| Record ID | K844277 |
|---|---|
| Device Name | OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR |
| Applicant | Omikron Scientific, Ltd. |
| Product Code | DXG · Cardiovascular |
| Decision Date | Feb 15, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.
