21 CFR 870.2370 — Tester, Electrode, Surface, Electrocardiographic
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2370
Identification
An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRC | Tester, Electrode, Surface, Electrocardiographic | 2 | 11 | 3rd Party |
