21 C.F.R. § 892.1410

Current through October 31, 2024
Section 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 .

21 C.F.R. §892.1410

55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322 , Jan. 14, 2000