21 CFR 870.2810 — Recorder, Paper Chart
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2810
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSF | Recorder, Paper Chart | 1 | 87 |
