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

---
identifier: "/us/cfr/t21/s870.2300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm)."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.2300"
section_name: "Cardiac monitor (including cardiotachometer and rate alarm)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---


# 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(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).