§892.1410. Nuclear electrocardiograph synchronizer.
21 C.F.R. § 892.1410
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.
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 2322, 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 2322, Jan. 14, 2000]