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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 892: RADIOLOGY DEVICES
Subpart B: Diagnostic Devices
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.
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]
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