View all text of Subpart B [§ 892.1000 - § 892.2080]
§ 892.1410 - Nuclear electrocardiograph synchronizer.
(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.