21 C.F.R. § 870.2810 Paper chart recorder.
Title 21 - Food and Drugs
(a) Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer. (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 the limitations in §870.9. [45 FR 7907–7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices
§ 870.2810 Paper chart recorder.
