Paper chart recorder.

21 C.F.R. § 870.2810
in effectEffective: 2024-07-01
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(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.

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21 C.F.R. § 870.2810 — Paper chart recorder | Code of Federal Regulations | Corpus