§892.1970. Radiographic ECG/respirator synchronizer.
21 C.F.R. § 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. 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.
Notes, amendments, and revision history
Amendments
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Amendments
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]