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Title 21 Part 892 → Subpart B → §892.1390

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1390

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1390

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1390


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.1390   Radionuclide rebreathing system.

(a) Identification. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.