StacksVerified U.S. regulatory reference

21 CFR §870.2810

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (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.