RMI RESPIRATORY GATING SYSTEM MODEL 301
Device Facts
| Record ID | K854976 |
|---|---|
| Device Name | RMI RESPIRATORY GATING SYSTEM MODEL 301 |
| Applicant | Radiation Measurements, Inc. |
| Product Code | IXO · Radiology |
| Decision Date | May 7, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1970 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.
