21 CFR § 868.5165 - Nitric oxide administration apparatus.

---
identifier: "/us/cfr/t21/s868.5165"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5165 - Nitric oxide administration apparatus."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5165"
section_name: "Nitric oxide administration apparatus."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY 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: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.5165 Nitric oxide administration apparatus.

(a) *Identification.* The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.

(b) *Classification.* Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

[65 FR 11465, Mar. 3, 2000]