21 CFR 892.1970 — Synchronizer, Ecg / Respirator, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1970
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 1 | 4 |
