Cardiovascular Devices; Classification of Electrocardiograph Electrodes
Information
Type
Rule
Regulated products
Published
July 21, 2011
Last updated
July 21, 2011
Description
Document number 2011-18391. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)