§ 892.1970. Radiographic ECG/respirator synchronizer.
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/us/cfr/t21/s§ 892.1970·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]