GENERATOR, R-WAVE
Device Facts
| Record ID | K790213 |
|---|---|
| Device Name | GENERATOR, R-WAVE |
| Applicant | Amr Co. |
| Product Code | IYY · Radiology |
| Decision Date | Mar 22, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.