21 CFR 870.2340 — Electrocardiograph
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2340
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DPS | Electrocardiograph | 2 | 575 | 3rd Party |
| MLC | Monitor, St Segment | 2 | 2 | 3rd Party |
