federal_register: 2011-18391

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-18391 Cardiovascular Devices; Classification of Electrocardiograph Electrodes Rule 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. 2011-07-21 2011 7 https://www.federalregister.gov/documents/2011/07/21/2011-18391/cardiovascular-devices-classification-of-electrocardiograph-electrodes https://www.govinfo.gov/content/pkg/FR-2011-07-21/pdf/2011-18391.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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