§ 882.1790. Ocular plethysmograph.
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/us/cfr/t21/s§ 882.1790·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).
(b)Classification. Class III (premarket approval).
(c)Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any ocular plethysmograph that was in commercial distribution before May 28, 1976. Any other ocular plethysmograph shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004]
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§ 882.1790
Ocular plethysmograph.
Fed. Reg.×2
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