21 C.F.R. § 892.1970 Radiographic ECG/respirator synchronizer.
Title 21 - Food and Drugs
(a) Identification. A radiographic ECG/respirator synchronizer is a device intended to be used tocoordinatean x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle. (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 2323, Jan. 14, 2000]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1970 Radiographic ECG/respirator synchronizer.
