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21 CFR 870.2810

§ 870.2810 Paper chart recorder.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 870.2810, § 870.2810 Paper chart recorder, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89943
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.