21 C.F.R. § 892.1970
Radiographic ECG/respirator synchronizer.
Cite as 21 C.F.R. § 892.1970 (2026)
(a)
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.
(b)
Classification.
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.
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]
- Cross-references to the CFR
- 892.9.