eCFR Reference Browser

---

title: "21 CFR §878.5070"

source: "https://www.ecfr.gov/current/title-21/section-878.5070"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "878"

part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "878.5070"

section_subject: "Air-handling apparatus for a surgical operating room."

cfr_reference: "21 CFR 878.5070"

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. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

(b)Classification. Class II.

§878.5070 - Air-handling apparatus for a surgical operating room.