eCFR Reference Browser

---

title: "21 CFR §870.2300"

source: "https://www.ecfr.gov/current/title-21/section-870.2300"

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: "C"

subpart_subject: "Cardiovascular Monitoring Devices"

section_number: "870.2300"

section_subject: "Cardiac monitor (including cardiotachometer and rate alarm)."

cfr_reference: "21 CFR 870.2300"

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. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

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

§870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).