§ 892.1410. Nuclear electrocardiograph synchronizer.
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/us/cfr/t21/s§ 892.1410·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.
(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 2322, Jan. 14, 2000]