eCFR Reference Browser

---

title: "21 CFR §870.1435"

source: "https://www.ecfr.gov/current/title-21/section-870.1435"

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: "B"

subpart_subject: "Cardiovascular Diagnostic Devices"

section_number: "870.1435"

section_subject: "Single-function, preprogrammed diagnostic computer."

cfr_reference: "21 CFR 870.1435"

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 single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

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

§870.1435 - Single-function, preprogrammed diagnostic computer.