# Cardiovascular Devices; Classification of Electrocardiograph Electrodes
> **Food and Drug Administration** · Final rule. · Published 2011-07-21 · Effective 2011-08-22 · 76 FR 43582
## Document
- **Document number:** 2011-18391
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 43582
- **CFR reference:** 21 CFR 870
- **Publication date:** 2011-07-21
- **Effective date:** 2011-08-22
- **HHS docket:** Docket No. FDA-2007-N-0092
## Abstract

The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/07/21/2011-18391/cardiovascular-devices-classification-of-electrocardiograph-electrodes)
---
*AI Analytics · CC0 1.0*