21 C.F.R. § 892.1970

Current through October 31, 2024
Section 892.1970 - Radiographic ECG/respirator synchronizer
(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 .

21 C.F.R. §892.1970

55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323 , Jan. 14, 2000