21 CFR 892.1410 – Nuclear electrocardiograph synchronizer
Current as of: 2024 | Check for updates
|
Other versions
(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.