eCFR Reference Browser

---

title: "21 CFR §870.3640"

source: "https://www.ecfr.gov/current/title-21/section-870.3640"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "D"

subpart_subject: "Cardiovascular Prosthetic Devices"

section_number: "870.3640"

section_subject: "Indirect pacemaker generator function analyzer."

cfr_reference: "21 CFR 870.3640"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.

(b)Classification. Class II (performance standards).

§870.3640 - Indirect pacemaker generator function analyzer.